Overview

Bioequivalence Study of Colchicine Tablets

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.
Phase:
Phase 1
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Colchicine
Probenecid