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NCT01021020 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Colchicine Tablets
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01021020: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT01021020 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01021020, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.
Primary Outcome
The maximum or peak concentration that colchicine reaches in the plasma.
Interventions
- DRUG Colchicine
- DRUG Colchicine/Probenecid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT01021020 record still lists
NCT01021020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Colchicine is the first listed.
NCT01021020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01021020 about?
NCT01021020 is a clinical study titled "Bioequivalence Study of Colchicine Tablets". This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also de...
What is the current status of trial NCT01021020?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2007-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT01021020?
The interventions under investigation include: Colchicine (DRUG), Colchicine/Probenecid (DRUG).
Who is sponsoring clinical trial NCT01021020?
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 NCT01021020's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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