NCT07166796 - a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 1, 2006

Primary Completion Date

January 31, 2007

Study Completion Date

January 31, 2007

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.