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NCT01017003 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study With Colchicine in Healthy Volunteers
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01017003: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT01017003 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01017003, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
Primary Outcome
maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions
Interventions
- DRUG colchicine tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT01017003 record still lists
NCT01017003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which colchicine tablets is the first listed.
NCT01017003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01017003 about?
NCT01017003 is a clinical study titled "Pharmacokinetic Study With Colchicine in Healthy Volunteers". This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
What is the current status of trial NCT01017003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT01017003?
The interventions under investigation include: colchicine tablets (DRUG).
Who is sponsoring clinical trial NCT01017003?
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 NCT01017003's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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