CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
singe dose 15mg +5 moredrug
Likely dose
singe dose 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT07166796
NCT07166796Phase 1Completed
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Tolvaptan Oral Administration Phase I Clinical Trial

Otsuka Beijing Research Institute·interventional·Posted Sep 10, 2025·Updated Sep 10, 2025

In Brief

A Phase 1 clinical trial evaluating singe dose 15mg, single dose 30mg, and 4 other interventions for Health Subjects. Completed, enrolled 64 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealth Subjects
Countries--
CollaboratorsChinese Academy of Medical Sciences, Fuwai Hospital

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2025
Enrollment StartOct 1, 2006
Primary CompletionJan 31, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10 months ago

Interventions

singe dose 15mgdrug

succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.

single dose 30mgdrug

succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.

single dose 60mgdrug

succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.

single dose 120mgdrug

succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.

multi dose 30mgdrug

radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 30mg Tolvaptan. First day, with no feeding, take single 30mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.

multi dose 60mgdrug

radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 60mg Tolvaptan. First day, with no feeding, take single 60mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.