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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

Page last updated: August 20, 2015

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