Bioequivalence Study of Colchicine Tablets

NCT01021020 | Completed Phase 1 Results

• 1 other identifier: MPC-004-07-1001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

bioequivalence; fasting; fed; healthy

Outcome Measures

Primary Outcomes (3)

• Maximal Plasma Concentration (Cmax)

  The maximum or peak concentration that colchicine reaches in the plasma.

  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

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

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.

  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

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

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.

  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

Study Arms (3)

1

EXPERIMENTAL

Colchicine (fasted)

Drug: Colchicine

2

EXPERIMENTAL

Colchicine (fed)

Drug: Colchicine

3

ACTIVE COMPARATOR

Colchicine/Probenecid (fasted)

Drug: Colchicine/Probenecid

Interventions

Colchicine DRUG

0.6mg tablet administered after a fast of at least 10 hours

Also known as: COLCRYS TM

1

Colchicine/Probenecid DRUG

0.5mg/500mg tablet administered after a fast of at least 10 hours

3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Conditions

Fasting; Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Colchicine; Probenecid

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Anthony R Godfrey, Pharm.D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: November 26, 2009
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 9, 2009
• Results First Posted: November 26, 2009

Record last verified: 2009-12

Locations

US (1)