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NCT00833664 · ClinicalTrials.gov registry record · Phase 1
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00833664: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
NCT00833664 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 22 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00833664, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.
Primary Outcome
Bioequivalence based on Cmax
Conditions Studied
Interventions
- DRUG Terbinafine HCl 250mg tablets
- DRUG Lamisil® 250 mg Tablets
Study Locations (1)
Pennsylvania
- Novum Pharmaceutical Research Services - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2002-01 |
| Est. Completion | 2002-01 |
| Phase | Phase 1 |
What the finished NCT00833664 record still lists
NCT00833664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Terbinafine HCl 250mg tablets is the first listed.
NCT00833664 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00833664 about?
NCT00833664 is a clinical study titled "Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions". The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.
What is the current status of trial NCT00833664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2002-01. Estimated completion is 2002-01.
What conditions does trial NCT00833664 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00833664?
The interventions under investigation include: Terbinafine HCl 250mg tablets (DRUG), Lamisil® 250 mg Tablets (DRUG).
Who is sponsoring clinical trial NCT00833664?
This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00833664 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00833664's enrollment target sits among peer trials
22 844th of 1090 higher than 235 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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