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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 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01021020
The ClinicalTrials.gov registry entry for NCT01021020 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 2 interventions - of which Colchicine is the first listed.
NCT01021020 reports 0 study locations.
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.
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