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Bioequivalence Study of Colchicine Tablets

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01021020
First received: August 12, 2009
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Colchicine
Drug: Colchicine/Probenecid
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Randomized, 3-Way Crossover Bioequivalence Study of Single Dose Colchicine Tablets and Effect of Food

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Maximal Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Colchicine (fasted)
 Drug: Colchicine
0.6mg tablet administered after a fast of at least 10 hours
Other Name: COLCRYS TM
Experimental: 2
Colchicine (fed)
 Drug: Colchicine
0.6mg tablet administered after a standardized high-fat, high-calorie breakfast
Other Name: COLCRYS TM
Active Comparator: 3
Colchicine/Probenecid (fasted)
 Drug: Colchicine/Probenecid
0.5mg/500mg tablet administered after a fast of at least 10 hours

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021020

Locations
United States, North Dakota
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
Principal Investigator: Anthony R Godfrey, Pharm.D. PRACS Institute, Ltd.
  More Information

Additional Information:
Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
Daily Med - Posting of Recently Submitted Labeling to the FDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT01021020     History of Changes
Other Study ID Numbers: MPC-004-07-1001
Study First Received: August 12, 2009
Results First Received: August 12, 2009
Last Updated: December 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mutual Pharmaceutical Company, Inc.:
bioequivalence
fasting
fed
healthy

Additional relevant MeSH terms:
Colchicine
Probenecid
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Uricosuric Agents
Renal Agents

ClinicalTrials.gov processed this record on May 23, 2013