NCT07166796

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

Tolvaptan Oral Administration Phase I Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Subjects

Interventions

Type	Name	Description
DRUG	singe dose 15mg	succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.
DRUG	single dose 30mg	succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.
DRUG	single dose 60mg	succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.
DRUG	single dose 120mg	succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.
DRUG	multi dose 30mg	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.
DRUG	multi dose 60mg	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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-01-31
• Completion: 2007-01-31
• First posted: 2025-09-10
• Last updated: 2025-09-10