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Bioequivalence Study of Colchicine Tablets

2014-08-27 03:17:43 | BioPortfolio

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.

Description

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 0.5mg with probenecid 500mg), administered under fasting conditions. It will also determine the bioavailability of the test product following a standard high-fat meal and evaluate the safety and tolerability of the test product. Twenty-eight healthy, non-smoking, non-obese (BMI 81-30 kg/m2 and BW ≥110 lbs), 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive one of three dosing regimens in sequence with washout periods of at least 14 days between dosing periods. After a fast of at least 10 hours, subjects will receive either, one tablet of colchicine 0.6 mg, one tablet of colchicine 0.6 mg after a standardized high-fat,high-calorie breakfast or 0.5mg/500mg colchicine/probenecid. All doses will be given with 240mL of room temperature water. Patients will be confined for at least 15 hours before and 24 hours after each dose with daily outpatient visits over the following 3 days. Blood will be drawn at times sufficient to adequately define the concentration time curves for each dosing regimen, which will be compared to assess the bioequivalence of the reference and test products and the effect of food on the test product. Subjects will also be monitored for adverse events throughout this same period.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Healthy

Intervention

Colchicine, Colchicine, Colchicine/Probenecid

Location

PRACS Institute, Ltd. - Cetero Research
Fargo
North Dakota
United States
58104

Status

Completed

Source

Mutual Pharmaceutical Company, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:43-0400

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Medical and Biotech [MESH] Definitions

Three, alpha, beta, and gamma isomers of ultraviolet degradation products of colchicine that lack many of the physiological actions of the parent; used as experimental control for colchicine actions.

A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. Its primary therapeutic use is in the treatment of gout, but it has been used also in the therapy of familial Mediterranean fever (PERIODIC DISEASE).

A microtubule subunit protein found in large quantities in mammalian brain. It has also been isolated from SPERM FLAGELLUM; CILIA; and other sources. Structurally, the protein is a dimer with a molecular weight of approximately 120,000 and a sedimentation coefficient of 5.8S. It binds to COLCHICINE; VINCRISTINE; and VINBLASTINE.

A genus of poisonous, liliaceous plants. The roots (corms) of Colchicum autumnale, the fall crocus or meadow saffron, yield COLCHICINE, which is used as a biochemical tool and to treat gout. Other members of this genus yield saffron dye, flavoring agents, and aromatics.

The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.

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