Drug-Drug Interaction Study Between Colchicine and Ketoconazole

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Pharmacokinetics
Interventions
DRUG

Colchicine

A single dose of colchicine 0.6 mg administered alone at 7:30 a.m. on Day 1.

DRUG

Ketoconazole

one 200 mg Ketoconazole tablet administered twice daily at 7:15 a.m. and 7:15 p.m. on Days 15-18 without regard to meals, then along with colchicine at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours; final dose of 200 mg administered at 7:15 p.m. on Day 19

DRUG

Colchicine

A single dose of colchicine 0.6 mg administered along with ketoconazole at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours

Trial Locations (1)

58104

PRACS Institute, Ltd. - Cetero Research, Fargo

All Listed Sponsors
lead

Mutual Pharmaceutical Company, Inc.

INDUSTRY

NCT00983216 - Drug-Drug Interaction Study Between Colchicine and Ketoconazole | Biotech Hunter | Biotech Hunter