Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00648713 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00648713: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648713 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648713, 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 tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fed 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 |
What the finished NCT00648713 record still lists
NCT00648713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Terbinafine Hydrochloride Tablets 250 mg is the first listed.
NCT00648713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648713 about?
NCT00648713 is a clinical study titled "Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg". The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fed conditions.
What is the current status of trial NCT00648713?
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 NCT00648713?
The interventions under investigation include: Terbinafine Hydrochloride Tablets 250 mg (DRUG), Lamisil® Tablets 250 mg (DRUG).
Who is sponsoring clinical trial NCT00648713?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648713's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia