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NCT00602251 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
A NA study of Onychomycosis, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00602251 is a NA study of Onychomycosis that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00602251, a NA study of Onychomycosis, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Conditions Studied
Interventions
- DRUG Terbinafine
Study Locations (1)
Missouri
- Gateway Medical Research, Inc. - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00602251
The ClinicalTrials.gov registry entry for NCT00602251 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (67% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Onychomycosis appearing as the primary indexed condition, and to 1 intervention - of which Terbinafine is the first listed.
NCT00602251 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT00602251 about?
NCT00602251 is a clinical study titled "Bioequivalency Study of Terbinafine Tablets Under Fed Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00602251?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2004-03. Estimated completion is 2004-04.
What conditions does trial NCT00602251 study?
This clinical trial studies the following conditions: Onychomycosis.
What interventions are being tested in trial NCT00602251?
The interventions under investigation include: Terbinafine (DRUG).
Who is sponsoring clinical trial NCT00602251?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602251 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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