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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 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01130051
The ClinicalTrials.gov registry entry for NCT01130051 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mutual Pharmaceutical Company, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Colchicine 0.6 mg tablet is the first listed.
NCT01130051 reports 0 study locations.
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.
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