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NCT01130051 · ClinicalTrials.gov registry record · Phase 1
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01130051: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT01130051 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130051, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
The maximum or peak concentration that Colcrys® reaches in the plasma
Interventions
- DRUG Colchicine 0.6 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT01130051 record still lists
NCT01130051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Colchicine 0.6 mg tablet is the first listed.
NCT01130051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01130051 about?
NCT01130051 is a clinical study titled "Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce". 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 sec...
What is the current status of trial NCT01130051?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-05. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01130051?
The interventions under investigation include: Colchicine 0.6 mg tablet (DRUG).
Who is sponsoring clinical trial NCT01130051?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01130051's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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