Clinical trials: Healthy Male Adults
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Male Adults
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two…
- Trial name
- NCT03342963
- Testing
- ASC-01, Aripiprazole and sertraline
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety…
- Trial name
- NCT04481789
- Testing
- MT-1186, Rosuvastatin, Sildenafil
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shionogi
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Male & Female Healthy Volunteers
Bioavailability Study of COQUN ORAL FORMULATION
The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
- Trial name
- NCT03819491
- Testing
- COQUN ORAL FORMULATION
- Where
- Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- VISUfarma SpA
Healthy Participants
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
- Trial name
- NCT06492226
- Testing
- NKF-INS(A), EU-NovoRapid®, US-NovoLog®
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Healthy
Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults
The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy…
- Trial name
- NCT01299805
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Adult Subjects
Study of Oral Edaravone in Healthy Adult Males
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
- Trial name
- NCT04481750
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shionogi
Glaucoma, Ocular Hypertension
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in…
- Trial name
- NCT02108288
- Testing
- OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution, Latanoprost ophthalmic solution
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Adult Male
A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
- Trial name
- NCT02994394
- Testing
- OPC-41061
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Severe Renal Impairment
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B): The 2 groups will be comparable in terms of age, gender, and body mass index (BMI)…
- Trial name
- NCT01043094
- Testing
- Pitavastatin 4mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Healthy Volunteers
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact.
- Trial name
- NCT04273217
- Testing
- AV-1
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AbViro LLC
Renal Impairment
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK…
- Trial name
- NCT04909853
- Testing
- PF-07321332/ritonavir
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
- Trial name
- NCT02372097
- Testing
- SYR-472
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Single-Dose Study of MT203
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.
- Trial name
- NCT02354599
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
Staphylococcal Infections
V710 First-In-Man (FIM) Study (V710-001)
This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled, dose-ranging study in healthy adults 18 to 55…
- Trial name
- NCT00303069
- Testing
- V710
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese…
- Trial name
- NCT01202071
- Testing
- Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets, Rabeprazole sodium, 20 mg Tablets
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
- Trial name
- NCT01561300
- Testing
- Nutrition intervention study with a black tea extract, Nutrition intervention study with a control
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Unilever R&D