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Bioequivalence Study of Colchicine Tablets

NCT01021020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-12-09

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Colchicine

0.6mg tablet administered after a fast of at least 10 hours

DRUG

Colchicine

0.6mg tablet administered after a standardized high-fat, high-calorie breakfast

DRUG

Colchicine/Probenecid

0.5mg/500mg tablet administered after a fast of at least 10 hours

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony R Godfrey, Pharm.D. · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021020 on ClinicalTrials.gov