Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

September 30, 2008

Conditions
Healthy
Interventions
DRUG

BI 201335 NA

"1. 480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10~2. 240 mg BI 201335 NA bid from day 11 to 23"

DRUG

Caffeine

days 1, 10 and 19

DRUG

Warfarin sodium

days 1, 10 and 19

DRUG

Vitamin K

days 1, 10 and 19

DRUG

Omeprazole

days 1, 10 and 19

DRUG

Dextromethorphan hydrobromide

days 1, 10 and 19

DRUG

Midazolam HCl solution

Days 3 and 21

DRUG

Midazolam HCl oral syrup

days 1, 10 and 19

DRUG

Digoxin

Days 2 and 20

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY