Clinical trials: Healthy Male/Female Subjects
Pharmacokinetics
Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers
This study was designed to compare the bioavailability of the Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd…
- Trial name
- NCT05124730
- Testing
- Metformin 500mg prolonged release tablets (JSC Farmak, Ukraine), Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
- Where
- Czechia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy, Enteric Hyperoxaluria
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2).
- Trial name
- NCT05650112
- Testing
- FB-001
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Federation Bio Inc.
Insomnia
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
- Trial name
- NCT00291187
- Testing
- 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162
- Where
- 19 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Hypothalamic Obesity, Prader-Willi Syndrome
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
- Conditions
- Hypothalamic Obesity, Prader-Willi Syndrome, PWS
- Trial name
- NCT06239116
- Testing
- Part C: RM-718, Part D: RM-718
- Where
- 7 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Healthy
An Open-Label Food Effect Study of Telotristat Etiprate
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy…
- Trial name
- NCT02157584
- Testing
- Telotristat etiprate
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Type2 Diabetes Mellitus, Chronic Kidney Disease
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes…
- Trial name
- NCT07619157
- Testing
- ONO-3310
- Where
- Japan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
Primary objective: Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to…
- Trial name
- NCT01129375
- Testing
- clopidogrel, omeprazole
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sanofi
Acute Pain
A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body
The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the…
- Trial name
- NCT03761407
- Testing
- 100 mg GRT0151Y, 125 mg GRT0151Y, 150 mg GRT0151Y
- Where
- France
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy Adults
Safety, Tolerability, Pharmacokinetics and Food Effects of Oral EC5026 in Healthy Subjects
The purpose of the study is to provide safety, tolerability, pharmacokinetics and food effects data of a single 8 mg oral dose of EC5026 in healthy subjects.
- Trial name
- NCT04908995
- Testing
- EC5026 oral tablet
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EicOsis Human Health Inc.
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
- Trial name
- NCT01297192
- Testing
- solifenacin succinate, mirabegron
- Where
- France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
- Trial name
- NCT02183571
- Testing
- Merck Glucophage® high dose, BMS Glucophage® high dose, Merck Glucophage® low dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer Study
A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects
This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to determine the comparative pharmacokinetic profile of the Test Investigational Medicinal Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid…
- Trial name
- NCT02256423
- Testing
- REFERENCE 1: Nurofen® 200 mg tablet, REFERENCE 2: Ibuprofen 200 mg soft gel capsule, ibuprofen 200 mg soft gel capsule
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Simbec Research
Drug-drug Interaction
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
- Trial name
- NCT04650542
- Testing
- HBI-3000, Paroxetine
- Where
- 2 sites in United States, Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- HUYABIO International, LLC.
Chronic Kidney Disease
A Study to Assess the Safety and Pharmacokinetics of Verinurad and Allopurinol in Asian and Chinese Subjects
This is a randomized, placebo controlled, double-blind study with two separate cohorts to assess safety, tolerability and pharmacokinetics of verinurad and allopurinol in healthy subjects.
- Trial name
- NCT03836599
- Testing
- Verinurad, Allopurinol
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers, Pharmacokinetics of ASP1941
Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults
This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy adult male and female subjects.
- Trial name
- NCT01678287
- Testing
- ASP1941
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Gout
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in…
- Trial name
- NCT03272425
- Testing
- lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Renal Insufficiency
Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.
- Trial name
- NCT01316055
- Testing
- Dalfampridine-ER
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Acorda Therapeutics