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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: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT00961116 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The maximum or peak concentration that the drug reaches in the plasma.
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 |
What the finished NCT00961116 record still lists
NCT00961116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Fenofibric Acid (Fibricor™) 105 mg Tablet is the first listed.
NCT00961116 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00961116's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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