Search clinical trials for: Japanese PK bridging

Total 5775 results

Merckle GmbH

Completed

PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants

Pharmacokinetics | Pharmacodynamics

United Kingdom
Celgene

Completed

Japanese Pharmacokinetic Bridging Study for CC-93538

Healthy Volunteers

United States
Pfizer

Completed

A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects

Healthy

United States
Otsuka Beijing Research Institute

Recruiting

PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes

Myelodysplastic Syndromes

China
Chiesi Farmaceutici S.p.A.
ICON plc

Recruiting

Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease (RISE)

Fabry Disease

Japan
Lumosa Therapeutics Co., Ltd.

Recruiting

A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

Acute Ischemic Stroke

United States
Cook MyoSite

Not yet recruiting

Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1) (JPN1)

Stress Urinary Incontinence
Vir Biotechnology, Inc.
GlaxoSmithKline

Completed

A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants

Covid19

United States
Principia Biopharma, a Sanofi Company

Completed

Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects

Healthy Volunteers

United States
Genentech, Inc.

Active, not recruiting

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Advanced/Metastatic Tumors

Spain, United States, Korea, Republic of, Australia, France, Japan, Canada
Incyte Corporation

Active, not recruiting

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Primary Myelofibrosis | Myelofibrosis | Post Essential Thrombocythemia Myelofibrosis | Post Polycythemia Vera Myelofibrosis

United States, Spain, United Kingdom, Korea, Republic of, China, Japan, France, Turkey, Germany, Israel, Poland, Belgium, Italy, Austria, Denmark, Finland, Norway
Amgen

Active, not recruiting

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

KRAS p.G12C Mutant Advanced Solid Tumors

United States, France, Canada, Spain, Belgium, Korea, Republic of, Austria, Australia, Hungary, Greece, Germany, Japan, Romania, Switzerland, Brazil, Portugal
Incyte Corporation

Active, not recruiting

To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Primary Myelofibrosis | Myelofibrosis | Post Essential Thrombocythemia Myelofibrosis | Post Polycythemia Vera Myelofibrosis

United States, Spain, United Kingdom, Korea, Republic of, Belgium, France, Israel, China, Japan, Italy, Germany, Taiwan, Poland, Austria, Finland, Hungary, Norway, Romania, Turkey
Ono Pharmaceutical Co. Ltd

Completed

Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Healthy Volunteers

Japan
Ono Pharmaceutical Co. Ltd

Completed

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

Healthy Volunteers

Japan
UCB Biopharma SRL

Completed

A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharamacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B

Healthy Study Participants

United States
Oneness Biotech Co., Ltd.

Active, not recruiting

A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

Atopic Dermatitis

United States
Sanofi

Completed

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

Rheumatoid Arthritis

United States
Amgen

Completed

Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants

Healthy Volunteers
AstraZeneca

Completed

Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population

Hypertension

United States
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...
Merck KGaA, Darmstadt, Germany

Completed

PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

Healthy

United Kingdom
Portola Pharmaceuticals

Completed

A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects

Bleeding

United States
Chinook Therapeutics, Inc.

Completed

Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects

Healthy Volunteer

United States
PMV Pharmaceuticals, Inc

Completed

Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers

Healthy Volunteers

United States
Pfizer

Completed

Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants

Healthy

Belgium
Altavant Sciences GmbH
Parexel; Altavant Sciences, Inc.

Completed

Multiple-Ascending Dose in Japanese Patients Bridging Study

Healthy

United States
Merck Sharp & Dohme LLC

Completed

Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)

Skin Diseases, Infectious | Bacteremia | Soft Tissue Infections

Japan
Sanofi

Completed

Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants

Multiple Sclerosis Healthy Subjects

United Kingdom
Organon and Co

Completed

Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)

Controlled Ovarian Stimulation
Teva Branded Pharmaceutical Products R&D, Inc.

Completed

To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

Pharmacokinetics

United States
TWi Biotechnology, Inc.

Completed

Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study

Healthy Subjects

Canada
Chiesi Farmaceutici S.p.A.

Completed

PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians

Chronic Obstructive Pulmonary Disease | Asthma

United Kingdom
Cytokinetics

Completed

Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

Heart Failure With Reduced Ejection Fraction

Japan
Zealand Pharma

Completed

A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.

Healthy

Netherlands
Knopp Biosciences
Biogen

Completed

Dexpramipexole Japanese PK Study

Amyotrophic Lateral Sclerosis

United Kingdom
Takeda

Completed

A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants

Healthy Volunteers

Japan
Pfizer's Upjohn has merged with Mylan to form Viatris...

Terminated

An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Japan
Theravance Biopharma

Completed

Multiple Dose Ethnobridging PK Study in Healthy Subjects

Inflammatory Bowel Diseases | IBD

United States
GlaxoSmithKline

Completed

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects

Healthy Volunteers

United Kingdom
Gilead Sciences

Terminated

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR-3)

Nonalcoholic Steatohepatitis

Hong Kong, United States, Spain, United Kingdom, Australia, Taiwan, Belgium, Canada, India, Japan, Korea, Republic of, Singapore, Puerto Rico, France, Israel, Austria, Germany, Italy, Malaysia, New Zealand, Mexico, Poland, Switzerland, Netherlan... and more
Nobelpharma

Completed

NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Bioavailability Study

United States
Merck Sharp & Dohme LLC

Completed

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

Anesthesia, General
Repros Therapeutics Inc.

Completed

Proellex® Pharmacokinetic Bridging Study II (PK)

Healthy

United States
Merck Sharp & Dohme LLC

Completed

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

Anesthesia, General
Merck Sharp & Dohme LLC

Completed

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)

Anesthesia, General
AstraZeneca

Completed

The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

Type 1 Diabetes Mellitus

Japan
Pfizer

Completed

A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Healthy

Japan
Aegerion Pharmaceuticals, Inc.
Richmond Pharmacology Limited

Completed

Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C

Healthy Volunteer

United Kingdom
Pfizer

Completed

Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects

Healthy

United States
Celgene

Completed

PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects

Healthy

United States

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