Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Colchicine 0.6 mg tablet (Drug); Colchicine 0.6 mg tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s): Matthew Davis, M.D., Study Chair, Affiliation: Mutual Pharmaceutical Company, Inc.
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 sprinkled on applesauce
(1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects
following an overnight fast. A secondary objective is to evaluate the safety and
tolerability of this regimen in healthy volunteers. All study subjects will be monitored
for adverse events throughout the study period.
Clinical Details
Official title: A Pilot Bioavailability Study of Colcrys® Tablet 0.6 mg Versus Colcrys® Tablets 0.6 mg Crushed and Sprinkled on Applesauce Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Maximum Plasma Concentration (Cmax)Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
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 sprinkled on applesauce
(1 tablespoon) 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 sprinkled on 1 tablespoon of applesauce (followed by 240 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, 1 hour ± 30 minutes post-dose and upon
discharge from the clinical facility. Subjects will be monitored throughout their
participation in the study for adverse reactions.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 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
Locations and Contacts
Novum Pharmaceutical Research Services, Las Vegas, Nevada 89121, United States
Additional Information
Starting date: May 2010
Last updated: May 10, 2011
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