bioihbjkbjnl/mcl2 huggingface dataset:
MK0524A Bioequivalence Study (0524A-059)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: niacin (+) laropiprant (Source 1); Comparator: niacin (+) laropiprant (Source 2)
Intervention description: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.; Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg
      Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject is willing to follow all study guidelines

        Exclusion Criteria:

          -  Subject has or has a history of any disease or condition that might confound the
             results of the study or make participation unsafe
Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects
Condition: Healthy
Intervention: BI 207127 + faldaprevir
Intervention description: fixed dose combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics
      of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with
      faldaprevir in healthy male and female subjects.
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Condition: Diabetes Mellitus
Intervention: OAP-189; placebo comparator
Intervention description: Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation); Group 1 & 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects
      with type 2 diabetes who are taking metformin for their diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and
             <=11.0% and a fasting glucose level <=280 mg/dL.

          -  Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on
             study day 1.

          -  Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight >=50 kg.

          -  Subjects must be otherwise generally healthy, but may be enrolled with a stable
             chronic illness, if it is well controlled and does not interfere with the primary
             objective of the study.

          -  Subjects must currently be treated for diabetes with metformin alone at a total daily
             dose of >=1gm (administered QD or BID) and that dose must have been stable for at
             least 4 weeks before study day 1.

          -  Nonsmoker.

        Exclusion Criteria:

          -  Any significant disease with the exception of diabetes mellitus.

          -  Any surgical or medical condition that may interfere with the absorption,
             distribution, metabolism, or excretion of the investigational product.

          -  Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
             study day 1.

          -  Any clinically important problems in physical examination results, vitals sign
             measurements, ECGs, or clinical laboratory test results.

          -  Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
             hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

          -  Positive findings of urine drug screen

          -  Use of any investigational or non-permitted prescription drug within 30 days before
             investigational product administration.
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: PDC-1421; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Major depressive disorder; Depression

Summary:

      The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,
      find the effective adequate dose for the next stage of the study, and accumulate information
      of possible mechanism of its anti-depressive effect.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 20-65 years.

          2. Subjects must be able to understand and willing to sign informed consent.

          3. Female subjects of child-bearing potential must test negative to pregnancy and use
             appropriate birth control method from the beginning of study to the 15 days later
             after ending of study.

          4. Laboratory data: red blood cell count(RBC),white blood cell count(WBC), platelets,
             hematocrit, hemoglobin, prothrombin time(PT), partial thromboplastin time
             (aPTT),aspartate transaminase(AST),alanine aminotransferase(ALT), Lactate
             dehydrogenase(LDH), total bilirubin, blood urea nitrogen(BUN),serum creatinine, free
             thyroxine (FT4), thyroid-stimulating hormone (TSH) level,sodium, potassium, calcium,
             glucose, are all within the normal range.

          5. No significantly abnormal findings on physical examination, ECG and vital sign.

        Exclusion Criteria:

          1. With any clinically significant neurological, gastrointestinal, renal,
             hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other
             major disorders as determined by the Investigator.

          2. A positive drug screen.

          3. Any mental disorder diagnosed by board-certificated psychiatrist through detailed
             diagnostic interview.

          4. Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS.

          5. The intensity of suicidal ideation in the past 6 months is no less than 4 defined by
             the C-SSRS.

          6. Have received any prescribed medicine, investigational drug or any non prescribed
             medicine (including herbal remedies) with 14 days prior to enroll this study.
A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: Alectinib; Posaconazole
Intervention description: Alectinib will be administered as a single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants).; Posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal on Days 8 to 14 (Period 2) and Days 15 to 18 or 21 (Period 3).
Intervention MeSH terms: Posaconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label study will investigate whether multiple oral doses of posaconazole affect the
      single dose pharmacokinetics of alectinib in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) between 18 to 32 kilogram per square meter (kg/m^2)

          -  Male volunteers must use effective contraception as outlined in the protocol

          -  Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee,
             tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until
             discharged

          -  Willingness to avoid prolonged sun exposure and guard against sunburn during study and
             follow-up

        Exclusion Criteria:

          -  Clinically significant medical history or findings in physical examination, vital
             signs, or laboratory test results prior to study start

          -  Positive screening tests for hepatitis B or C, human immunodeficiency virus (HIV),
             alcohol, drugs of abuse, or tobacco

          -  Women of childbearing potential, or males with pregnant or lactating partners

          -  Regular smoking within 6 months prior to first dosing. Participants should avoid smoky
             environments for at least 1 week prior to each cotinine screen

          -  Excessive alcohol consumption

          -  Use of any metabolic inducers (including herbals such as St. John's Wort) within 4
             weeks or 5 half-lives (whichever is longer) before the first dose of study medication,
             including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine,
             phenytoin and phenobarbital

          -  Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to
             entry into the clinical site until study follow-up

          -  Participation in an investigational drug or device study within 45 days (or 6 months
             for biologic therapies) prior to first dosing
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Condition: Healthy
Intervention: BI 113608 PIB; BI 113608; BI 113608; BI 113608; pantoprazole 40 mg STADA; BI 113608
Intervention description: powder for oral solution; conventional tablet formulation; conventional tablet formulation; conventional tablet formulation; film-coated tablet; conventional tablet formulation
Intervention MeSH terms: Pantoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the trial is to investigate the relative bioavailability, influence of
      pantoprazole coadministration and food effect of different oral formulations of BI 113608 in
      healthy male subjects
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Condition: Malaria
MeSH terms: Malaria
Intervention: KAE609; Placebo
Intervention description: iv bolus administration over approximately 2 min for doses < 75 mg (Cohorts A1, A2 and B1)
iv infusion over approximately 10 min for doses ≥ 75 mg (Cohorts A3, A4, A5 and B2); matching placeo for iv administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; tolerability; pharmacokinetics; healthy volunteers; phase 1; malaria; intravenous; iv; KAE609; Placebo

Summary:

      This was a randomized, subject and investigator-blinded, placebo-controlled, single and
      multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and
      tolerability of KAE609 given in the vein.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy male and female subjects 18 to 55 years of age inclusive, and in good health
             as determined by past medical history, physical examination, vital signs,
             electrocardiogram, and laboratory tests.

          -  Subjects must weigh at least 50 kg to participate in the study, and must have a body
             mass index (BMI) within the range of 18.0 - 30.0 kg/m2.

        Key Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of Screening, or within 30 days
             of dosing, whichever is longer; or longer if required by local regulations.

          -  Significant illness which has not resolved within two (2) weeks prior to initial
             dosing.

          -  Pregnant or nursing (lactating) women.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Sexually active males unwilling to use a condom during intercourse while taking
             investigational drug and for at least 2 weeks after last dose of investigational drug.
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Condition: Smoking
Intervention: nicotine
Intervention description: nicotine transdermal patch
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an
      alternative supplier delivers the same nicotine blood profile as that of the currently
      approved NTS with a polyisobutylene adhesive from the current supplier.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 19-27 kg/m2

          -  smokes >10 cigarettes per day for preceeding 6 months

        Exclusion Criteria:

          -  inability to stop smoking during study
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
Condition: Biological Availability
Intervention: methylprednisolone; methylprednisolone; methylprednisolone
Intervention description: powder for oral suspension 4 mg/mL single dose (8 mL); powder for oral suspension 4 mg/mL singe dose (8 ml); tablet 32 mg single dose
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)

Summary:

      A new formulation of methylprednisolone is being developed. A study is needed to determine
      the drug availability using the new formulation, a powder for reconstitution into a
      suspension, versus the current commercially available tablet formulation in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;

          -  a total body weight >45 kg (99 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease;

          -  Any condition possibly affecting drug absorption (eg, gastrectomy).
Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Condition: Healthy
Intervention: Simvastatin; SSP-004184SS
Intervention MeSH terms: Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184
      on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal healthy male and female volunteers

          -  Serum ferritin, hemoglobin and erythrocyte indices within normal range

        Exclusion Criteria:

          -  Evidence of any active or chronic disease
Afatinib in Subjects With Kidney Dysfunction
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: Afatinib healthy; Afatinib severe renally impaired; Afatinib moderate renally impaired
Intervention MeSH terms: Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the current study is to investigate the influence of moderate to
      severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in
      comparison to a control group with normal renal function.

      The assessment of safety and tolerability will be an additional objective of this trial and
      will be evaluated by descriptive statistics.
    

Eligibility criteria:

        Inclusion criteria:

          -  Despite renal impairment (group 1 and 2) healthy males or females according to the
             investigators assessment, as based on the following criteria: a complete medical
             history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate
             (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.

          -  Glomerular filtration rate (GFR), estimated according to:

             -- MDRD (Modification of Diet in Renal Disease)-formula:

               -  eGFR (estimated Glomerular Filtration Rate) [ml/min/1.73m²]= 175 x Serum
                  Creatinine-1.154 x age-0.203 (if male)

               -  eGFR[ml/min/1.73m²]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)

               -  30 to 59 mL/min for moderate renal impairment group 1

               -  15 to 29 mL/min for severe renal impairment group 2

               -  = 90 mL/min for healthy volunteers group 3

          -  Age =18 and =79 years

        Exclusion criteria:

          -  Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
             and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g.
             repeated measurement of systolic blood pressure < 90 mmHg (millimeter of mercury) or >
             140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg, repeated measurement of
             pulse rate < 45 bpm (beats per minute) or > 90 bpm.

          -  Any evidence of a clinically relevant concomitant disease.

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological, dermatological or hormonal disorders.

          -  Relevant gastrointestinal tract surgery (except appendectomy).

          -  Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric
             disorders or neurological disorders.

          -  History of photosensitivity or recurrent rash.

          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders.
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
Condition: Dose Finding Study
Intervention: TAK-137; Placebo
Intervention description: TAK-137 tablets; TAK-137 placebo-matching tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to characterize the safety and tolerability profile of TAK-137
      when administered as a single dose of tablets at escalating dose levels in healthy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of
             age inclusive at the time of informed consent and first study medication dose.

          2. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2,
             inclusive at Screening.

          3. Is able to comply with the protocol and is willing to sign the informed consent prior
             to undergoing any study-related procedures.

        Exclusion Criteria:

          1. Has a known hypersensitivity to any component of the formulation of TAK-137.

          2. Has a medical condition such as mental retardation that can cause cognitive
             impairment.

          3. Has a risk of suicide according to the Investigator's clinical judgment (eg, per
             Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the
             previous 6 months).

          4. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic
             disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy,
             asthma hypoxemia, hypertension, seizures, or allergic skin rash.

          5. There is any finding in the participant's medical history, physical examination, or
             safety laboratory tests (including safety electroencephalogram [EEG]) giving
             reasonable suspicion of a disease that would contraindicate taking TAK-137, or a
             similar drug in the same class, or that might interfere with the conduct of the study.
             This includes, but is not limited to, peptic ulcer disease, seizure disorders, and
             cardiac arrhythmias.

          6. Has taken any excluded medication, supplements, or food products listed in the
             Excluded Medications and Dietary Products table.