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Bioequivalence Study of Colchicine Tablets

Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Colchicine (Drug); Colchicine (Drug); Colchicine/Probenecid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mutual Pharmaceutical Company, Inc.

Official(s) and/or principal investigator(s):
Anthony R Godfrey, Pharm.D., Principal Investigator, Affiliation: PRACS Institute, Ltd.

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.

Clinical Details

Official title: Randomized, 3-Way Crossover Bioequivalence Study of Single Dose Colchicine Tablets and Effect of Food

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

Primary outcome:

Maximal Plasma Concentration (Cmax)

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adult volunteers, male and female, 18 to 45 years of age, inclusive, with BMI

between 18-30 kg/m2, inclusive, and weighing at least 110 pounds.

- Female volunteers must be postmenopausal, surgically sterile, or must commit to

abstain from heterosexual contact or to use two methods of reliable birth control. Exclusion Criteria:

- Subjects who report receiving any investigational drug within 28 days prior to

initiation of dosing.

- Subjects who report presence or history of significant cardiovascular, respiratory,

renal, gastrointestinal, immunologic, hematologic, endocrine, neurologic, or psychiatric disease.

- Subjects with clinical lab results outside accepted reference range, or reactive

screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.

- Subjects who report a history of allergies to colchicine or related drugs, or history

of other clinically significant allergies including drug allergies.

- Subjects who report a clinically significant illness during the 4 weeks prior to

initiation of dosing.

- Subjects who report a history of drug or alcohol addiction or abuse within the past

year, or who demonstrate a positive drug abuse screen.

- Subjects who currently use or have used tobacco products within 6 months prior to

dose administration.

- Subjects who report donating greater than 150 ml of blood within 28 days or donating

plasma within 14 days prior to initiation of dosing.

- Subjects who have a positive pregnancy screen, or are currently pregnant or

breastfeeding.

Locations and Contacts

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

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

Starting date: September 2007
Last updated: December 1, 2009

Page last updated: August 23, 2015

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