NCT01001052

Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions

Relative Bioavailability of Colcrys™ (Colchicine, USP) 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mutual Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast.

Detailed description

The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young, healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast. On study Day 1 following an overnight fast, twenty healthy, non-smoking, non-obese male and female subjects between the ages of 18 and 30 and twenty generally healthy, non-smoking, non-obese male and female subjects over 60 years of age will be administered one single dose of Colcrys™ (1 x 0.6 mg tablet). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Colcrys. Blood sampling will continue on a non-confined basis at 36, 48, 60 and 72 hours post-dose. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Vitals signs (temperature, respiratory rate, pulse rate and blood pressure) will be measured in the sitting position prior to dosing. Seated blood pressure and pulse will be measured at approximately 1, 3, 6 and 12 hours after dosing and prior to release from the facility. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Colcrys™ (colchicine)	0.6 mg taken by mouth on day 1

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-10-23
• Last updated: 2010-09-28
• Results posted: 2010-09-14