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NCT00983905 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of Colchicine and Theophylline
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00983905: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT00983905 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983905, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theophylline administered as a single dose. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the entire study period.
Primary Outcome
The maximum or peak concentration that theophylline drug reaches in the plasma.
Interventions
- DRUG Theophylline
- DRUG Colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT00983905 record still lists
NCT00983905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Theophylline is the first listed.
NCT00983905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983905 about?
NCT00983905 is a clinical study titled "Drug-Drug Interaction Study of Colchicine and Theophylline". Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theop...
What is the current status of trial NCT00983905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-08. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00983905?
The interventions under investigation include: Theophylline (DRUG), Colchicine (DRUG).
Who is sponsoring clinical trial NCT00983905?
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 NCT00983905's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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