Bioavailability Study of Colcrys® in Apple Juice

NCT ID: NCT01123395

Last Updated: 2011-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.

Detailed Description

The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice (followed by 220 mL of water) according to the randomization schedule. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and at 1 hour ± 30 minutes post dose. Subjects will be monitored throughout their participation in the study for adverse reactions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Colcrys® (colchicine USP) 0.6 mg intact tablet

One Colcrys® (colchicine USP) 0.6 mg intact tablet taken by mouth

Group Type: EXPERIMENTAL

colchicine 0.6 mg tablet

Intervention Type: DRUG

One Colcrys® 0.6 mg intact tablet taken by mouth

Colcrys® 0.6 mg tab in apple juice

One Colcrys® 0.6 mg tablet crushed and dissolved in apple juice

Group Type: EXPERIMENTAL

colchicine 0.6 mg tablet

Intervention Type: DRUG

One Colcrys® 0.6 mg tablet dissolved in apple juice

Interventions

colchicine 0.6 mg tablet

One Colcrys® 0.6 mg intact tablet taken by mouth

Intervention Type: DRUG

colchicine 0.6 mg tablet

One Colcrys® 0.6 mg tablet dissolved in apple juice

Intervention Type: DRUG

Other Intervention Names

Colcrys®; Colcrys®

Eligibility Criteria

Inclusion Criteria

• Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m²

Exclusion Criteria

• Recent participation (within 30 days) in other research studies
• Recent significant blood donation or plasma donation
• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
• History of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study
• Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year
• History of or psychiatric disorders occurring within the last two years that required hospitalization or medication
• Presence of a medical condition requiring regular treatment with prescription drugs
• Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug
• Drug allergies or sensitivity to colchicine
• Positive test results for drugs of abuse at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mutual Pharmaceutical Company, Inc.

Principal Investigators

Darin B Brimhall, D.O.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

Novum Pharmaceutical Research Services

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

MPC-004-10-1001

Identifier Type: -

Identifier Source: org_study_id