At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Terbinafine HCl 250mg tablets +1 moredrug
Likely dose
Terbinafine HCl 250mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Terbinafine HCl 250mg tablets and Lamisil® 250 mg Tablets for Healthy. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2002
Primary CompletionJan 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 2, 2009
Enrollment StartJan 1, 2002
Primary CompletionJan 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Terbinafine HCl 250mg tabletsdrug
1 x 250 mg
Lamisil® 250 mg Tabletsdrug
1 x 250 mg