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NCT01601132 · ClinicalTrials.gov registry record · Phase 4
Drug Interaction Study of Colchicine and Theophylline
A Phase 4 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01601132 is a Phase 4 study that has completed, run by Takeda. The registered enrollment target is 30 participants.
The verdict
NCT01601132, a Phase 4 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- 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 | 2012-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01601132
The ClinicalTrials.gov registry entry for NCT01601132 describes a study currently listed as completed, categorized as Phase 4. 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 Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which theophylline is the first listed.
NCT01601132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01601132 about?
NCT01601132 is a clinical study titled "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 NCT01601132?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01601132?
The interventions under investigation include: theophylline (DRUG), colchicine (DRUG).
Who is sponsoring clinical trial NCT01601132?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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