Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study.

ABSTRACT:

Background

To determine the pharmacokinetics (PK), pharmacodynamics (PD) and safety of tolvaptan in healthy Chinese males.

Methods

Three separate clinical trials were carried out on healthy Chinese males aged 18-45 years. Fifty received a single dose of tolvaptan of 7.5, 15, 30, 60 and 120 mg. In addition, 36 received multiple doses of 7.5, 30 and 60 mg once a day for 7 days. The primary outcomes measured were the PK parameters of tolvaptan and its two metabolites (DM-4103, DM-4107). Secondary endpoints included serum electrolytes, urine volume and water intake, which were monitored as pharmacological indicators. The safety profile was also evaluated in detail.

Results

After the administration of a single dose of tolvaptan, dose proportionality was observed for the ar

SUBMITTER: Liu H 

PROVIDER: S-EPMC12679040 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature