- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123395
Bioavailability Study of Colcrys® in Apple Juice
April 29, 2011 updated by: Mutual Pharmaceutical Company, Inc.
A Pilot Bioavailability Study of Colcrys® Tablet 0.6 mg Versus Colcrys® Tablet 0.6 mg Crushed and Dissolved in Apple Juice Under Fasting Conditions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89121
- Novum Pharmaceutical Research Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Colcrys® (colchicine USP) 0.6 mg intact tablet
One Colcrys® (colchicine USP) 0.6 mg intact tablet taken by mouth
|
One Colcrys® 0.6 mg intact tablet taken by mouth
Other Names:
One Colcrys® 0.6 mg tablet dissolved in apple juice
Other Names:
|
Experimental: Colcrys® 0.6 mg tab in apple juice
One Colcrys® 0.6 mg tablet crushed and dissolved in apple juice
|
One Colcrys® 0.6 mg intact tablet taken by mouth
Other Names:
One Colcrys® 0.6 mg tablet dissolved in apple juice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
The maximum or peak concentration that Colcrys® reaches in the plasma
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)]
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
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 Colcrys® plasma concentration to the elimination rate constant.
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Darin B Brimhall, D.O., Novum Pharmaceutical Research Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 12, 2010
First Submitted That Met QC Criteria
May 13, 2010
First Posted (Estimate)
May 14, 2010
Study Record Updates
Last Update Posted (Estimate)
May 3, 2011
Last Update Submitted That Met QC Criteria
April 29, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPC-004-10-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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