bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Condition: Heartburn
MeSH terms: Heartburn
Intervention: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet; Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water; Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Intervention description: A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods; A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods; A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Magnesium Hydroxide; Famotidine; Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew
      tablet taken without water and with water compared to the Famotidine/Antacid tablet taken
      with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subject is not pregnant or lactating, Females of childbearing potential must
             use reliable means of contraception during the course of the study

          -  Subject is in good health

          -  Subject is able to abstain from smoking during the 24-hour periods before and during
             each treatment day

        Exclusion Criteria:

          -  Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI
             surgery

          -  Subject has a history of asthma or severe allergies to drugs or foods

          -  Subject currently uses prescribed or nonprescribed drugs on a regular basis

          -  Subject has a recent history of drug/alcohol abuse

          -  Subject consumes more than 6 cups of coffee per day

          -  Subject has unconventional or extreme dietary habits

          -  Subject has donated blood or has been in a clinical trial in which they received an
             investigational drug during the past 30 days

          -  Subject has a history of allergy or intolerance to antacids

          -  Female subject is known to be pregnant or is not using reliable means of contraception
A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Renal Insufficiency, Chronic
Intervention: Preladenant
Intervention description: After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a two part study to compare the PK of preladenant administered to participants with
      CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK
      of participants with severe CRI to healthy participants. Part 2 will compare the PK of
      participants with moderate CRI and participants with mild CRI to healthy participants. The
      primary hypotheses are that the plasma area under the concentration-time curve from time 0 to
      infinity after single dosing (AUC0-∞) of preladenant in participants with either severe,
      moderate or mild CRI is similar to that of matched healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive

          -  Has mild to severe CRI and not on dialysis (Participants with normal renal function
             are to be matched to subjects with renal impairment)

          -  Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges

          -  Free of any clinically significant disease that would interfere with the study
             evaluations (except related to his/her renal disease and comorbid conditions)

        Exclusion Criteria:

          -  Females who are pregnant, intend to become pregnant (within 3 months of ending the
             study), or are nursing/breastfeeding

          -  Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of any drug

          -  Had a renal transplant or are on dialysis

          -  Has a history of any infectious disease within 4 weeks

          -  Is positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV)

          -  Has donated blood or had a blood transfusions in the past 60 days

          -  Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic
             episodes) which could interfere with their ability to participate in the trial

          -  Has a history of malignancy

          -  Has evidence of suicidality or is at risk for self-harm or harm to others
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
Condition: Healthy
Intervention: Xenaderm; Placebo
Intervention description: 20mg under Finn chambers; 20mg under Finn chambers
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: wound healing; phototoxicity; Healthy Subjects

Summary:

      The product is being tested to see if exposure to light causes toxic reactions on the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

        Exclusion Criteria:

          -  Under 18 years of age
Safety and Tolerability of Seroguard Use
Condition: Adhesion
MeSH terms: Tissue Adhesions
Intervention: Seroguard; Placebos
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: laparoscopic cholecystectomy
Masking: Double (Participant, Investigator)
Masking description: The present study was planned as double-blind, placebo-controlled study. With the aim of maximum objectification of end point, neither Medical Investigator, nor patients had access to the code of healthcare institution.
The test drug or the placebo were received by the sites as ready for use and blinded vials, 200 mL each. Each vial had individual number and identification of contents ("Drug A" or "Drug B"). Conformity of identification of Seroguard or the placebo was not disclosed to the sites.
Before surgery, the Medical Investigator prepared required number of vials according to identification of the drug on the vial and identification of the group in randomization envelope of patient. Individual number of each vial administered to a patient was recorded in documentation of site.
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adhesion; Safety

Summary:

      The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez,
      Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that
      patients from the both groups had the similar safety profile
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients.

          2. Age from 18 to 75 years, inclusive.

          3. Signed informed consent form.

          4. One of the following diagnoses as per International classification of diseases -10:

             4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of
             gallbladder without cholecystitis

          5. Indications for planned laparoscopic cholecystectomy.

        Exclusion Criteria:

          1. Recall of informed consent by patient.

          2. Non-compliance with the rules of participating in the study by patient.

          3. Getting pregnant.

          4. Required conversion during surgery.

          5. Required repeated surgery.

          6. Development of diseases described in non-inclusion criteria, required use of drugs not
             provided by the protocol in patient.

          7. Another reasons appeared during the study and interfering conduction of the study as
             per the protocol.
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Condition: Hepatitis C, Treatment Naïve, Genotype 1 Patients
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: IMO-2125; Saline
Intervention description: IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.; Subcutaneous injection once per week for four weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose
      levels of IMO-2125 in combination with standard weight based ribavirin (investigational
      treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients
      will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo
      and RBV arm (3 patients).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented genotype 1

          -  HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL

        Exclusion Criteria:

          -  Positive test for HIV or HbsAg

          -  Inadequate bone marrow, liver, and renal function

          -  Treatment with any IFN-based or other experimental or antiviral therapies - prior or
             current

          -  Other significant medical disease

          -  Concurrent or planned treatment during the study
Subcutaneous Pharmacokinetics of Belatacept
Condition: Transplantation
Intervention: belatacept; Placebo
Intervention description: single dose, 116 days; Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept
      Administered Subcutaneously to Healthy Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 18 to 65 years old

          -  Subjects must weigh less than or equal to 100 kg

        Exclusion Criteria:

          -  Inability to tolerate injections or IV infusions

          -  autoimmune disorders

          -  TB

          -  herpes

          -  HCV

          -  HBV

          -  HIV

          -  bacterial or viral infection

          -  history of cancer
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
Condition: Healthy Participants
Intervention: TAK-438
Intervention description: TAK-438 tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy
      adult Chinese participants after both single and multiple dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or female Chinese participant.

          2. Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26
             kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).

          4. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day
             1) until the Follow-up Visit on Day 18.

          5. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1)
             until the Follow-up Visit on Day 18.

          6. Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19]
             genotyping).

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant cardiovascular disease or other abnormality,
             which may impact the ability of the participant to participate or potentially confound
             the study results.

          2. Is lactose intolerant or has a known hypersensitivity to any component of the
             formulation of TAK-438.

          3. Has poor peripheral venous access.

          4. Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day
             1; or participant has donated or lost more than 200 mL or more of his or her blood in
             the last 28 days.

          5. Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive
             Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus,
             or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months)
             gastrointestinal disease that would be expected to influence the absorption of drugs.
Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Condition: Schizophrenia; Mental Disorder; Nervous System Diseases
MeSH terms: Nervous System Diseases; Schizophrenia; Mental Disorders
Intervention: Aripiprazole, OPC-14597
Intervention description: 5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
Intervention MeSH terms: Aripiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: OPC-14597; Aripiprazole; Schizophrenia

Summary:

      To determine the safety and tolerability of multiple-dose administrations of aripiprazole
      intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female individuals between 18 and 64 years, inclusive, at the time of
             informed consent.

          -  Prior history of tolerating aripiprazole per investigator's judgement.

        Exclusion Criteria:

          -  Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180
             days.

          -  Subjects who use more than one antipsychotic medication at screening.

          -  Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to
             dosing and for the duration of the trial.

          -  Subjects who participated in any clinical trial involving a psychotropic medication
             within 1 month prior to enrollment.

          -  Subjects currently in an acute relapse of schizophrenia.

          -  Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.

          -  Subjects who are considered treatment-resistant to antipsychotic medications.
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Intervention: terbutaline sulphate delivered dose; terbutaline sulphate metered dose
Intervention description: 0.4 mg terbutaline sulphate (delivered dose) per inhalation; 0.5 mg terbutaline sulphate (metered dose) per inhalation
Intervention MeSH terms: Terbutaline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers, pharmacokinetic, inhalation

Summary:

      Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via
      current version of Turbuhaler with inhalation via a new version
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female and male volunteers aged between 18 and 65 years, both inclusive

          2. Healthy as judged by the Principal Investigator after medical history, physical
             examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C
             antibody tests) and assessments of pulse rate and blood pressure

          3. Ability to use a Turbuhaler according to the provided instructions, as judged by the
             Principal Investigator or the study nurse

          4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least
             50 kg and no more than 100 kg -

        Exclusion Criteria:

          1. History or presence of respiratory, gastrointestinal, hepatic or renal disease or any
             other condition known to interfere with absorption, distribution, metabolism or
             excretion of drugs (except for cholecystectomy)

          2. Current smokers or those who have smoked or used nicotine products within the previous
             3 months should be excluded

          3. Plasma donation within 1 month of screening or any blood donation or blood loss of
             more than 500 mL during the 3 months prior to screening

          4. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
             judged by the Principal Investigator or history of hypersensitivity to terbutaline (or
             drugs of a similar chemical structure or class) or inhaled lactose

          5. Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit
             1) or on admission to the study centre (Day -1) prior to administration of the
             investigational medical product (IMP) on Day 1 -
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
Condition: Renal Impairment
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Intervention: Denosumab
Intervention description: Adminstered by subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective was to evaluate the incidence of clinically significant hypocalcemia
      following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic
      kidney disease (CKD) and CKD on dialysis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects at least 18 years old with severe CKD (defined as creatinine clearance < 30
             mL/min at both screening assessments) and CKD requiring hemodialysis

          -  Additional inclusion criteria apply

        Exclusion Criteria:

          -  Subjects must have calcium, phosphate, and magnesium levels appropriate for their
             condition and must not have other uncontrolled co-morbidities.

          -  Additional exclusion criteria apply
Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Condition: Healthy
Intervention: low dose; normal dose; low dose
Intervention description: efavirenz single dosing once daily; efavirenz once daily; Efavirenz single dosing once daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when
      administered together.

      To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe
      , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

        Exclusion criteria:

          1. Any finding on medical examination and ECG (Electrocardiography) deviating from normal

          2. Active diseases

          3. History of photosensitivity or rash