Clinical trials: Healthy Male/Female Subjects
Mild Moderate, or Severe Renal Impairment
An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects
The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in subjects with a different degree of renal impairment.
- Trial name
- NCT01442259
- Testing
- AFQ056
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE.
- Trial name
- NCT07074327
- Testing
- VX-407, LNG/EE, NGM/EE
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy
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
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…
- Trial name
- NCT01737996
- Testing
- BI 207127 + faldaprevir
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Prophylaxis of Ross River Virus Infection
Ross River Virus (RRV) Vaccine Study
The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate the consistency of manufacture…
- Trial name
- NCT01242670
- Testing
- Ross River Virus Vaccine
- Where
- 17 sites in Australia
- Volunteers
- 1,968 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Renal Impairment
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
- Trial name
- NCT01359579
- Testing
- varespladib methyl
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Anthera Pharmaceuticals
Healthy
Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg ODT
- Trial name
- NCT00659685
- Testing
- Ondansetron, Zofran ODT
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
End-Stage Renal Disease
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram…
- Trial name
- NCT02289703
- Testing
- Rivaroxaban 15 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Renal Impairment
Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment
The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.
- Trial name
- NCT01613690
- Testing
- NVA237
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteer
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
- Trial name
- NCT03252002
- Testing
- BAY1101042
- Where
- 2 sites in Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Bayer
Type 2 Diabetes Mellitus
Sotagliflozin Bioequivalence Study
Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and…
- Trial name
- NCT03211195
- Testing
- Sotagliflozin (SAR439954)
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women
Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.
- Trial name
- NCT06916702
- Testing
- BI 3031185, Midazolam
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Solid Tumor
Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole.
- Trial name
- NCT04989829
- Testing
- SHR6390、Omeprazole
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Recurrent Genital Herpes Simplex Type 2
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 in Part B in…
- Trial name
- NCT06698575
- Testing
- ABI-1179
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Pharmacokinetics, Pharmacodynamics
A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability
This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races.
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Effect of Race
- Trial name
- NCT01958047
- Testing
- ASP3652
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Osteoporosis
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
- Trial name
- NCT00769418
- Testing
- odanacatib
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
The objective of this study is to evaluate and compare the bioavailability of mesalamine
- Trial name
- NCT03327558
- Testing
- Apriso 0.375G ER CAP, APRISO 375 mg extended-release capsules
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Subjects
ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.
- Trial name
- NCT03361540
- Testing
- ASP8302
- Where
- Japan
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Cardiac Repolarization
A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy Subjects
The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on electrocardiogram (ECG) measurements.
- Trial name
- NCT01232413
- Testing
- ASP1941, Moxifloxacin
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Renal Insufficiency
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers.
- Trial name
- NCT00731523
- Testing
- fingolimod (FTY720)
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Novartis
Chronic Obstructive Pulmonary Disease
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same…
- Trial name
- NCT05431426
- Testing
- CH6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.