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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 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 30 participants.
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.
Interventions
- DRUG Theophylline
- DRUG Colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983905
The ClinicalTrials.gov registry entry for NCT00983905 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 Theophylline is the first listed.
NCT00983905 reports 0 study locations.
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.
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