Clinical trials: Healthy Male and Female Subjects
Healthy Subjects
A Bioavailability Study of FL-101 in Healthy Male and Female Subjects
This will be a single-center, randomized, open-label, single dose, parallel study to assess the absolute bioavailability of FL-101 when administered via the subcutaneous (SC) and intravenous (IV) routes.
- Trial name
- NCT04983732
- Testing
- FL-101-Intravenous, FL-101-Subcutaneous
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Flame Biosciences
Healthy Subjects, Plasma Concentration of Mirabegron
A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
- Trial name
- NCT01747564
- Testing
- YM178 (mirabegron)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Pharmacokinetics of ASP8232
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease
This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232. In addition, the safety and tolerability will be assessed.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP8232, Pharmacodynamics of ASP8232, Chronic Kidney Disease (CKD)
- Trial name
- NCT02218099
- Testing
- ASP8232
- Where
- 3 sites in Bulgaria, Moldova and 1 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Diabetes Mellitus, Type 2
Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
This is a an open-label, randomized, single dose, four-way crossover, multi-stage study enrolling 20 healthy adult male and female subjects per part.
- Trial name
- NCT01725672
- Testing
- Metformin, 500 mg extended release tablet, Metformin, 1000 mg extended release tablet, Glimepiride, 1 mg immediate release tablet
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Insufficiency
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
- Trial name
- NCT01660295
- Testing
- Certoparin 3,000 IU Once Daily, Certoparin 3,000 IU Twice a Day, Certoparin 8,000 IU Once Daily
- Where
- Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
- Trial name
- NCT04512170
- Testing
- HEC585
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.
- Trial name
- NCT00847405
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state…
- Trial name
- NCT02273544
- Testing
- Asasantin ER (new formulation - low), Asasantin ER (new formulation - medium), Asasantin ER (new formulation - high)
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following oral administration of multiple rising doses over 4 weeks.
- Trial name
- NCT03868540
- Testing
- BI 1291583
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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.
Renal Impairment, Healthy
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of…
- Trial name
- NCT02647918
- Testing
- Sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Healthy
Relative Bioavailability of Telmisartan and SR26334 After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After Administration of Telmisartan and Clopidogrel Alone in Healthy Male and Female Subjects
Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of…
- Trial name
- NCT02262650
- Testing
- Telmisartan, Clopidogrel
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Asthma
An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604
The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing…
- Trial name
- NCT06157255
- Testing
- AZD4604 Inhalation Powder, 1 mg, [14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL), [14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Prostate Cancer, Endometriosis
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
- Trial name
- NCT02093390
- Testing
- TAK-385, Fluconazole, Atorvastatin
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Pharmacokinetic
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
- Trial name
- NCT04531150
- Testing
- INV-101
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Inversago Pharma Inc.
Gastroparesis
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach).
- Trial name
- NCT00562848
- Testing
- GSK962040
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gitelman Syndrome, Potassium Depletion
Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)
Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the urines. The investigators wonder whether progesterone or other adrenal hormon play the same role.
- Trial name
- DEPROGE (NCT02297048)
- Testing
- Potassium depletion
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Healthy
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Part I: To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306 Part II: To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil
- Trial name
- NCT02635750
- Testing
- BI 409306, Donepezil
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Autosomal Dominant Polycystic Kidney
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers
The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Oral AL01211 in healthy volunteers
- Trial name
- NCT04908462
- Where
- Australia
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- AceLink Therapeutics, Inc.
Severe Renal Impairment
A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine
The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.
- Trial name
- NCT01675973
- Testing
- RANEXA
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences