bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Condition: Healthy
Intervention: Epanutin Infatabs (Phenytoin); Dilantin Infatabs (Phenytoin)
Intervention description: Chewable Tablet, 50 mg, Single dose; Chewable Tablet, 50 mg, Single dose
Intervention MeSH terms: Phenytoin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: phenytoin; chewable tablets; dilantin; epanutin; infatabs; bioequivalence; Partial seizure; Tonic-clonic seizure

Summary:

      In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and
      Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a
      pivotal bioequivalence study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.

          -  An informed consent document signed and dated by the subject.

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormalities.

          -  Any condition possibly affecting drug absorption (e.g. gastrectomy).
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
Condition: Impaired Liver Function
Intervention: Proellex
Intervention description: Proellex 25 mg capsule, single dose
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 62 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and pharmacokinetics of two doses of orally administered
      Proellex® in female patients with impaired hepatic function and healthy volunteers with
      normal hepatic function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak, read, and understand English or Spanish and is willing and able to provide
             written informed consent on an IRB-approved form prior to the initiation of any study
             procedures;

          -  Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and
             39, inclusive, are preferred; however, subjects up to 62 years old, inclusive, may
             participate;

          -  Subjects with moderate hepatic insufficiency must meet the Class B level of the
             Child-Pugh criteria;

          -  Subjects must have evidence of stable hepatic impairment;

          -  If on medications for treatment of the complications of liver disease, and other
             concomitant chronic illnesses, subjects must have been taking the medications at a
             stable dose for at least 10 days prior to the first dosing date and are then to be
             continued at the same dose for the duration of the study;

          -  Non-smokers are preferred, but light to moderate smoking will be allowed (no more than
             10 cigarettes/day)

          -  Subject is willing to remain in the clinic for the screening visit and for two
             treatment visits (approximately 3 days for each treatment visit);

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Past or present history of an allergic reaction to the formulations administered in
             this study, or in the opinion of the Investigator, suggesting an increased potential
             for an adverse hypersensitivity;

          -  Pregnant or lactating females, or women who are attempting or expecting to become
             pregnant at any time during the study or one month after the study;

          -  A physical illness within three (3) months of the study that would interfere with the
             study as determined by the Investigator;

          -  An acute illness within five (5) days of study medication administration;

          -  Positive urine drug screen at the screening visit based on laboratory testing;

          -  Other exclusion criteria may apply
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan
Intervention description: Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to compare the amount of lasmiditan that gets into the
      blood stream and how long it takes the body to get rid of it, when given as a
      oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The
      information about any adverse effects experienced will be collected and the tolerability of
      lasmiditan when administered as OD tablet will also be evaluated.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 5 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical evaluation.

          -  Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds, or any components of the
             formulation of lasmiditan, or a history of significant atopy.

          -  Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.

          -  Have clinically significant abnormalities on ECG, as determined by investigator.

          -  Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal,
             endocrine, hematological, or neurological disorders capable of significantly altering
             the absorption, metabolism, or elimination of drugs; of constituting a risk when
             taking the study interventions; or of interfering with the interpretation of data.

          -  Have used or are intending to use over-the-counter or prescription medication,
             including dietary supplements, within 14 days prior to dosing and until study
             discharge (apart from occasional acetaminophen, hormonal contraception, or
             hormone-replacement therapy).
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: MT-1186
Intervention description: Suspension
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic
      Lateral Sclerosis Patients with gastrostomy
    

Eligibility criteria:

        Inclusion Criteria:

        The key criteria are listed below.

          -  Patients aged between 20 and 80 years at the time of informed consent

          -  Japanese patients

          -  Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or
             "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie
             House criteria

          -  ALS Patients with gastrostomy

          -  Patients who can consent to contraception

          -  Patients who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria:

        The key criteria are listed below.

          -  Patients in whom the possibility could not be ruled out that the current symptoms were
             symptoms of a disease requiring differential diagnosis, such as cervical spondylosis
             and multifocal motor neuropathy

          -  Patients undergoing treatment for malignancy.

          -  Patients who have presence of clinically significant liver, heart, or renal disease
             requiring hospitalization (except ALS) and infections requiring antibiotics. Patients
             who have a problem in general condition and are judged ineligible by the Investigator

          -  Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg

          -  Patients judged by the investigator (or subinvestigator) to be unsuitable for the
             study for any other reason
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Condition: Group B Streptococcus
Intervention: Group B streptococcus (GBS) vaccine- low dose; Group B streptococcus (GBS) vaccine- High dose; Placebo- Saline
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 678.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Group B streptococcus; GBS; Vaccine; Group B streptococcus (GBS) disease

Summary:

      This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy females 18-40 years of age inclusive.

        Exclusion Criteria:

          -  Individuals who are pregnant or nursing.

          -  Individuals who have had a previous immunization with a vaccine containing
             streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of
             study completion.

          -  Individuals with a history of severe allergic reactions after previous vaccination

          -  Individuals with designated blood tests that are not within normal range
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium; Comparator: isosorbide mononitrate (ISMN); Comparator: losartan + ISMN; Comparator: losartan + ISMN; Comparator: Placebo
Intervention description: Single dose losartan 100 mg in one of five treatment periods; Single dose ISMN 60 mg in one of five treatment periods; Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods; Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods; Single dose placebo only in one of five treatment periods
Intervention MeSH terms: Losartan; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will qualify a functional model that can measure central blood pressure and
      vascular compliance effects through noninvasive means.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is in good health with the exception of mild to moderate hypertension

          -  Patient is willing to comply with the study restrictions

          -  Patient does not smoke

        Exclusion Criteria:

          -  Patient has a history of any illness that might confound the results of the study or
             make participation in the study unsafe

          -  Patient is taking a prescription medication that is contraindicated for use with
             COZAAR® or IMDUR®

          -  Patient has a condition for which there is a warning, contraindication, or precaution
             against the use of COZAAR® or IMDUR®
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 700 mg IV; 350 mg SC; Placebo; 140 mg SC
Intervention description: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered
      as a single SC or IV dose.
    

Eligibility criteria:

        Inclusion Criteria:

        Part A:

          -  Able to provide written informed consent

          -  Healthy male or female between 18 to 45 years of age, inclusive at the time of
             screening

          -  Additional inclusion criteria apply

        Part B:

          -  18 - 55 years old inclusive at Screening

          -  Active but clinically stable, plaque psoriasis

          -  Psoriasis involving ≥ 10% of the body surface area

          -  A minimum PASI score of ≥ 10 obtained during the screening period

          -  Additional inclusion criteria apply

        Exclusion Criteria:

        Part A:

          -  History or evidence of a clinically significant disorder (including but not limited to
             cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition
             or disease that, in the opinion of the Investigator and Amgen physician would pose a
             risk to subject safety or interfere with the study evaluation, procedures or
             completion

          -  Underlying condition that predisposes the subject to infections (eg, uncontrolled
             diabetes - HbA1c > 7%, history of splenectomy)

          -  Additional exclusion criteria apply

        Part B:

          -  Active guttate, erythrodermic, or pustular psoriasis at the time of the screening
             visit

          -  Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the
             screening visit or between the screening visit and study drug initiation that would
             interfere with evaluations of the effect of investigational product on psoriasis

          -  Any condition that, in the judgment of the investigator, might cause this study to be
             detrimental to the subject

          -  Additional exclusion criteria apply
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Peglispro; Insulin Glargine
Intervention description: Daily doses administered SC.; Daily doses administered SC.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study has two parts. Each participant will receive a daily injection of insulin
      peglispro during one treatment period and a daily injection of insulin glargine during the
      other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures
      to look at how the body uses or stores fats while taking each study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than
             8.5%

          -  Otherwise fit and healthy

          -  Non smoker

        Exclusion Criteria:

          -  Taking medication or supplements other than insulin to control diabetes.

          -  Suffered a hypoglycemic event in the last 12 months that required hospitalization or
             have poor awareness of hypoglycemia

          -  Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic
             corticosteroids
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers
Condition: Healthy
Intervention: BI 1034020; Placebo to BI 1034020
Intervention description: intravenous part; intravenous part
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following
      intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of
      the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination
      of the bioavailability of subcutaneous injections of BI 1034020
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males based upon a complete medical history, including a physical examination,
             vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical
             laboratory tests

          2. Age within the range of 18 to 40 years

          3. Body mass index within the range of 18.5 and 29.9 kg/m2

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and local legislation.

        Exclusion criteria:

          1. Any finding in the medical examination (including blood pressure, pulse rate or
             electrocardiogram) deviating from normal and judged clinically relevant by the
             investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the
             ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed
             by repeat measurement

          2. Any evidence of a clinically relevant concomitant disease.

          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders.

          4. Surgery of the gastrointestinal tract (except appendectomy).

          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders.

          6. History of relevant orthostatic hypotension, fainting spells or blackouts.

          7. Chronic or relevant acute infections.
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
Condition: Healthy
Intervention: T80/A5 mg FDC tablet; T80/A5 mg FDC tablet; H12.5 mg tablet; T80/A5/H12.5 ng FDC tablet; H12.5 mf tablet; T80/A5/H12.5 mg FDC tablet
Intervention description: A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet; A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet; A HCTZ 12.5 mg tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will be performed as an open-label, randomised, single-dose, two-sequence,
      four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be
      randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once
      or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period.
      The length of admission will be 7 days in each period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects age =20 and =35 years; body weight: =50 kg and =80 kg; body mass
             index: =18.0 and =25.0 kg/m2

          -  Without any clinically significant findings and complications on the basis of a
             complete medical history, including the physical examination, vital signs (blood
             pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs),
             clinical laboratory tests

          -  Signed and dated written informed consent prior to admission to the trial in
             accordance with the Good Clinical Practice (GCP) and the local legislation.

        Exclusion criteria:

        - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal
        and of clinical relevance.