Clinical trials: Japanese Healthy Adult Males
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Embolism, Atrial Fibrillation and Venous Thrombosis
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male…
- Trial name
- NCT02537405
- Testing
- Rivaroxaban (BAY 59-7939), Rivaroxaban (Xarelto, BAY 59-7939)
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.
- Trial name
- NCT04878471
- Testing
- Pudexacianinium chloride
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Hyperphosphatemia
Bioequivalence Study of BAY77-1931 Granule
The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first…
- Trial name
- NCT01053676
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule, Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
- Where
- Japan
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Bayer
Attention Deficit Hyperactivity Disorder
A Bioequivalence (BE) Study in Healthy Subjects
To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects.
- Trial name
- NCT01177943
- Testing
- Atomoxetine
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male…
- Trial name
- NCT05858788
- Testing
- SAR441566
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteer
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
- Trial name
- DMB-3113-1 (NCT02927353)
- Testing
- DMB-3113, Adalimumab
- Where
- Japan
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Healthy Adult Male
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess…
- Trial name
- NCT04182958
- Testing
- (14C)-OPC-61815
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study of Macitentan, in Healthy Japanese Male Participants
The main purpose of this study is to evaluate the safety and tolerability after multiple-dose administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up to Dose 2 qd in Japanese healthy adult…
- Trial name
- NCT04500808
- Testing
- Macitentan Dose 1, Macitentan Dose 2, Macitentan Dose 3
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Spasmodic Torticollis
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).
- Trial name
- NCT00280384
- Testing
- E2014 (Botulinum toxin type B)
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Eisai Limited
Healthy
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil…
- Trial name
- NCT02530060
- Testing
- Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy Japanese Adult Male
A Phase 1, Single and Multiple Dose Study of TAK-137
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects.
- Trial name
- NCT02322606
- Where
- Japan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Takeda
Healthy Male
Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
- Trial name
- NCT04828265
- Testing
- Aldafermin
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
Clinical Pharmacology
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931.
- Trial name
- NCT03074058
- Testing
- Fosrenol ODT (Lanthanum Carbonate, BAY77-1931), Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Male Adults, Food Effect in Healthy Volunteers
A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male…
- Trial name
- NCT07549919
- Testing
- AJ201
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- AnnJi Pharmaceutical Co., Ltd.
Acute Venous and Arterial Thrombotic and Thromboembolic Events, Healthy Volunteers
A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 Years
Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels.
- Trial name
- NCT06562985
- Testing
- BAY3018250 Dose 1, BAY3018250 Dose 2 infusion, BAY3018250 Dose 2 injection
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Bayer
Japanese Healthy Adult Male Participants
A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male…
- Trial name
- NCT03042299
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
- Trial name
- NCT01799603
- Testing
- TMC435
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Single and Multiple Dose Study to Explore the Safety and Pharmacokinetics of JNJ-39758979 In Healthy Male Volunteers of Either Caucasian or Japanese Descent
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single doses of…
- Trial name
- NCT01081821
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.