Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00961116 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00961116 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 54 participants.
The verdict
NCT00961116, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this regimen will also be evaluated.
Interventions
- DRUG Fenofibric Acid (Fibricor™) 105 mg Tablet
- DRUG Fenofibrate (Tricor®) 145 mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2007-10 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00961116
The ClinicalTrials.gov registry entry for NCT00961116 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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 Fenofibric Acid (Fibricor™) 105 mg Tablet is the first listed.
NCT00961116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00961116 about?
NCT00961116 is a clinical study titled "Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)". This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to he...
What is the current status of trial NCT00961116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2007-10. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00961116?
The interventions under investigation include: Fenofibric Acid (Fibricor™) 105 mg Tablet (DRUG), Fenofibrate (Tricor®) 145 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT00961116?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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.