Bioequivalence Study of Colchicine Tablets

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01021020

Run by

Mutual Pharmaceutical Company, Inc.

People needed

28

Starts

2007-09-01

Expected to finish

2007-12-01

Last updated by the study team

2009-12-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.