Clinical trials: Male & Female Healthy Volunteers
Renal Failure
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
- Trial name
- HCT3012-X-106 (NCT00674856)
- Testing
- naproxcinod
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- NicOx
Drug-drug Interaction
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin
This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin.
- Trial name
- NCT03826602
- Testing
- Tucatinib, Metformin, Iohexol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Seagen Inc.
Healthy Volunteers, Pharmacologic Action
A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate
This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects…
- Trial name
- AZD3293DDI (NCT02010970)
- Testing
- Group 1 AZD3293, Group 2 AZD3293, Group 3 AZD3293
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infection, Human Immunodeficiency Virus
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of…
- Trial name
- NCT01231542
- Testing
- GSK1349572, Rifampin, Rifabutin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Type 2 Diabetes Mellitus, Healthy Subjects
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal…
- Trial name
- NCT03802487
- Testing
- Sotagliflozin (SAR439954), 14C-microtracer, Charcoal
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Young Volunteers, Healthy Elderly Volunteers
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293.
- Trial name
- NCT01739647
- Testing
- AZD3293
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Tuberculosis
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis.
- Trial name
- NCT01585636
- Testing
- SQ109
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Pharmacokinetic Analysis, Bioequivalence
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
Pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, bioequivalence study of Levetiracetam 1500 mg coated granules in sachet formulations and Keppra (Levetiracetam) 2 x…
- Conditions
- Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
- Trial name
- NCT07393022
- Testing
- Levetiracetam 1500 mg, Keppra® 750 mg
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Desitin Arzneimittel GmbH
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
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
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.
- Trial name
- NCT00882700
- Testing
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Renal Impairment
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.
To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.
- Trial name
- NCT02048787
- Testing
- Buparlisib
- Where
- 4 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Disease, Healthy Volunteers
A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine.
- Trial name
- NCT05800444
- Testing
- BAY3283142
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Solid Tumours
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and healthy subjects
- Trial name
- NCT02063204
- Testing
- selumetinib
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Insufficiency
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
- Trial name
- NCT03545087
- Testing
- Lanabecestat, Iohexol
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered…
- Trial name
- NCT02412449
- Testing
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Healthy
Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
Primary objective: Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to…
- Trial name
- NCT01129414
- Testing
- Clopidogrel, Omeprazole
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
A Double-blind, Randomised Study to Assess the Influence of Tiotropium (Spiriva®)
To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more than placebo
- Trial name
- NCT00257452
- Testing
- tiotropium 18 mcg or 54 mcg qd, moxifloxacin 200 mg
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Metabolism and Nutrition Disorder, Obesity
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC…
- Trial name
- NCT01044108
- Testing
- NNC 0070-0002-0453, '2-0453
- Where
- United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Mental Disorders
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Trial name
- NCT00449774
- Testing
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline