Clinical trials: Healthy Male Volunteers
Bioequivalence
Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg
Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions.
- Trial name
- NCT05145608
- Testing
- Lamotrigine ER tablet 50mg
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.
Healthy
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B).
- Trial name
- NCT01037725
- Testing
- AZD5847
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Solid Tumor
IMP4297 DDI (Drug-Drug Interaction)Trial in Healthy Male Volunteers
A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK Profiles of IMP4297 Capsules in Healthy Subjects
- Trial name
- NCT04584515
- Testing
- IMP4297 40 mg, IMP4297 100 mg
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Epilepsy
The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093
The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.
- Trial name
- NCT02170649
- Testing
- BIA 2-093
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy Volunteers
A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.
- Trial name
- NCT01954238
- Testing
- GCC-4401C, Rivaroxaban
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Benign Prostatic Hyperplasia
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects
- Trial name
- NCT07444385
- Testing
- AD-116, AD-1161
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Weightlessness
A 5-day Dry Immersion Study on 20 Healthy Male Volunteers
Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric.
- Trial name
- VIVALDI2 (NCT05493176)
- Testing
- Dry immersion
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Centre National d'Etudes Spatiales
Type 2 Diabetes Mellitus
Drug-drug Interaction Study (CKD-501, Ketoconazole)
The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
- Trial name
- NCT01330563
- Testing
- CKD-501, Ketoconazole
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Diabetes, Hyperlipidemias
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.
- Trial name
- NCT03690778
- Testing
- "Metformin" and "Rosuvastatin" seperately, JLP-1310
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Healthy Adult Volunteers
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
The objectives of this study are: To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
- Trial name
- NCT02182609
- Testing
- Kit for the Preparation of 99mTc-rhAnnexin V-128
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Advanced Accelerator Applications
Healthy Male Volunteers
Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
The study consists of 2 parts: Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the…
- Trial name
- NCT03863587
- Testing
- HLX12, Cyramza (Ramucirumab)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy
Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
- Trial name
- NCT00548678
- Testing
- intravenous diclofenac sodium (DIC075V), ketorolac, oral diclofenac (Cataflam)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Healthy Volunteers
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.
- Trial name
- NCT03457649
- Testing
- ARGX-113
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- argenx
Influenza
Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.
- Trial name
- NCT02955030
- Testing
- NSV0001, Influenza HA vaccine "Biken HA"
- Where
- Japan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Nitto Denko Corporation
Acinetobacter Baumannii-calcoaceticus Complex Infections
Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc).
- Trial name
- NCT03985410
- Testing
- ETX2514, moxifloxacin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Renal Failure, Chronic, End-Stage Renal Disease
PK of Serelaxin in Severe Renal Impairment and ESRD
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD)…
- Trial name
- CRLX030A2102 (NCT01875523)
- Testing
- Serelaxin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Healthy
Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers
Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as 4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence of this formulation compared to 200 mg NVP…
- Trial name
- NCT02194218
- Testing
- Nevirapine, low dose, Nevirapine, high dose
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Male Volunteers
Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension. To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus…
- Trial name
- NCT01948011
- Testing
- Racecadotril suspension, Racecadotril granules
- Where
- France
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Bioprojet
Healthy
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
- Trial name
- NCT02224079
- Testing
- BIIB 722 CL
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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