Clinical trials: Healthy Male/Female Subjects
Healthy
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects
- Trial name
- NCT01114152
- Testing
- AZD9742
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs.
- Trial name
- NCT02963701
- Testing
- Ibuprofen, Pseudoephedrine-HCl
- Where
- South Africa
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Duchenne and Becker Muscular Dystrophy, Polycytemia Vera
Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval
The study will evaluate the effect of a therapeutic dose and a supratherapeutic dose of ITF2357 on the QT/QTc interval.
- Trial name
- NCT04821063
- Testing
- ITF2357 10 mg/mL, Moxifloxacin Hydrochloride
- Where
- Canada
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Italfarmaco
Overactive Bladder
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.
- Trial name
- NCT02821312
- Testing
- DA-8010
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects
Study to investigate the relative bioavailability of orally administered dextromethorphan syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female subjects who are extensive metabolisers for CYP 2D6
- Trial name
- NCT02191709
- Testing
- Dextromethorphan syrup, Dextromethorphan soft pastilles
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment, Healthy Volunteer
A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function
This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment.
- Trial name
- NCT03192111
- Testing
- Entinostat
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Syndax Pharmaceuticals
Severe Renal Impairment, Healthy Subjects
A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease
The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
- Trial name
- NCT03165071
- Testing
- ACT-132577
- Where
- Czechia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects
The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.
- Trial name
- NCT02209688
- Testing
- ESR 1150 CL
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Metabolic Disorders, Non-alcoholic Steatohepatitis
A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects
This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in…
- Trial name
- NCT04142424
- Testing
- AZD2693
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Chronic Kidney Diseases, Magnetic Resonance Imaging
Material Balance Study of TQ-B3525
A clinical study to investigate the absorption, metabolism and excretion of [14C] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects…
- Trial name
- NCT05675202
- Testing
- TQ-B3525
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Kidney Failure, Chronic
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects.
- Trial name
- NCT01975337
- Testing
- Alisporivir
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Debiopharm International SA
Renal Impairment
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with…
- Trial name
- NCT03605277
- Testing
- Asciminib
- Where
- 2 sites in Bulgaria, Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
- Trial name
- NCT00999336
- Testing
- Betrixaban
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy
A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects
This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses…
- Trial name
- JSMAD (NCT01096563)
- Testing
- AZD9164
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension
Relative Bioavailability Study of One Amlodipine 10mg Tablet and One Rosuvastatin 20mg Tablet to Two Fixed Dose Combinations of Amlodipine (10mg) and Rosuvastatin (20mg) in Healthy Subjects Under Fasting Conditions
This is an open-label, single-centre, randomized, single dose, three-way crossover, six sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination (FDC) tablet formulations of amlodipine and…
- Trial name
- NCT02075619
- Testing
- Amlodipine+Rosuvastatin, GSK3074477 FDC - 1, GSK3074477 FDC - 2
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fed Conditions
The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL)…
- Trial name
- NCT00778739
- Testing
- CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Cough, Healthy
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate…
- Trial name
- NCT05570539
- Testing
- BLU-5937 IR, BLU-5937 ER
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bellus Health Inc. - a GSK company
HIV
A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers
The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers
- Trial name
- NCT01268839
- Testing
- TMC278, Efavirenz
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec, Inc