Phase 1
Completed N=16
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Healthy
Source: ClinicalTrials.gov NCT01130051 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 3.087; 2.616 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
3.087; 2.616 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
23.042; 19.216 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
28.550; 23.883 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01130051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.