Status:
COMPLETED
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 o...
Eligibility Criteria
Inclusion
- Healthy adults 18-30 years of age or generally healthy adults over 60 years of age (elderly subjects with minor renal impairment may be allowed to participate at the discretion of the investigator), non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) of 18-30 kg/m2.
Exclusion
- 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 excessive alcohol consumption during the past 12 months
- Significant history of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorder, diabetes or bleeding disorders, gastrointestinal disease or psychiatric disorders.
- Presence of a medical condition requiring regular treatment with prescription drugs
- Subjects who have used any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to the first dose and throughout the study
- Drug allergies or sensitivity to colchicine
- Positive test results for drugs of abuse at screening
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01001052
Start Date
October 1 2009
End Date
October 1 2009
Last Update
September 28 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.