Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Interventions
DRUG

Colchicine

A single dose of 0.6 mg colchicine administered alone at 7:15 am on Day 1 after an overnight fast of at least 10 hours.

DRUG

Diltiazem ER

One 240 mg diltiazem ER capsule administered daily at 7:15 am on Days 15 to 21.

DRUG

Colchicine

A single dose of 0.6 mg colchicine administered along with diltiazem ER at 7:15 am on Day 21 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

NCT00983372 - Drug-Drug Interaction Study Between Colchicine and Diltiazem ER | Biotech Hunter | Biotech Hunter