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NCT00647647 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00647647 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants.
The verdict
NCT00647647, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.
Interventions
- DRUG Terbinafine Hydrochloride Tablets 250 mg
- DRUG Lamisil® Tablets 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647647
The ClinicalTrials.gov registry entry for NCT00647647 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Terbinafine Hydrochloride Tablets 250 mg is the first listed.
NCT00647647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00647647 about?
NCT00647647 is a clinical study titled "Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg". The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.
What is the current status of trial NCT00647647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2004-02. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00647647?
The interventions under investigation include: Terbinafine Hydrochloride Tablets 250 mg (DRUG), Lamisil® Tablets 250 mg (DRUG).
Who is sponsoring clinical trial NCT00647647?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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