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

NCT07166796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07166796 on ClinicalTrials.gov