Bioequivalence Study of Colchicine Tablets
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Tracking Information | |||||
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First Received Date ICMJE | August 12, 2009 | ||||
Last Updated Date | December 1, 2009 | ||||
Start Date ICMJE | September 2007 | ||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01021020 on ClinicalTrials.gov Archive Site | ||||
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Bioequivalence Study of Colchicine Tablets | ||||
Official Title ICMJE | Randomized, 3-Way Crossover Bioequivalence Study of Single Dose Colchicine Tablets and Effect of Food | ||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 28 | ||||
Completion Date | December 2007 | ||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01021020 | ||||
Other Study ID Numbers ICMJE | MPC-004-07-1001 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc. | ||||
Study Sponsor ICMJE | Mutual Pharmaceutical Company, Inc. | ||||
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Investigators ICMJE |
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Information Provided By | Mutual Pharmaceutical Company, Inc. | ||||
Verification Date | December 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |