a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects

Phase 1 Completed 64 enrolled Otsuka Beijing Research Institute Chinese Academy of Medical Sciences, Fuwai Hospital · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.

Timeline

Start: 2006-10-01
Primary completion: 2007-01-31
Completion: 2007-01-31

Publications

Liu H, Liu T, Liu M, Zheng X, Zhong W, Zhao Q, Jiang J, Hu P, Li Y. Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study. Front Pharmacol. 2025 Nov 21;16:1713702. doi: 10.3389/fphar.2025.1713702. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Small molecule	15 mg	Oral
Subject	Tolvaptan	Small molecule	30 mg	Oral
Subject	Tolvaptan	Small molecule	60 mg	Oral
Subject	Tolvaptan	Small molecule	120 mg	Oral

Indications

No indication recorded.