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NCT00984009 · ClinicalTrials.gov registry record · Phase 1
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
A Phase 1 study of Pharmacokinetics, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00984009 is a Phase 1 study of Pharmacokinetics that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00984009, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of grapefruit juice on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.
Conditions Studied
Interventions
- DRUG Colchicine
- OTHER Grapefruit Juice
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Cetero Research - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-09 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00984009
The ClinicalTrials.gov registry entry for NCT00984009 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The listed sponsor is Mutual Pharmaceutical Company, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which Colchicine is the first listed.
NCT00984009 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.
Frequently Asked Questions
What is clinical trial NCT00984009 about?
NCT00984009 is a clinical study titled "A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice". Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of grapefruit juice on the pharmacokinetic profile of a single 0.6 mg dose of co...
What is the current status of trial NCT00984009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-09. Estimated completion is 2008-10.
What conditions does trial NCT00984009 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT00984009?
The interventions under investigation include: Colchicine (DRUG), Grapefruit Juice (OTHER).
Who is sponsoring clinical trial NCT00984009?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00984009 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.