Phase 1
N=28
Bioequivalence Study of Colchicine Tablets
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01021020 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Maximal Plasma Concentration (Cmax) — 2,503.04; 2,496.88; 1,706.03 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Colchicine (Drug); Colchicine/Probenecid (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mutual Pharmaceutical Company, Inc.
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Plasma Concentration (Cmax) |
2,503.04; 2,496.88; 1,706.03 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
12,588.61; 10,490.95; 8,090.05 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
14,112.52; 11,404.09; 8,481.41 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01021020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.