At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Famciclovir 500 mg Tablets +1 moredrug
Likely dose
Famciclovir 500 mg 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.
A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Famciclovir 500 mg Tablets and Famvir® 500 mg Tablets for Healthy. Completed, enrolled 36 participants across 2 sites in 2 countries.
Detailed Summary
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada, United States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionSep 2004
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartAug 1, 2004
Primary CompletionSep 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Famciclovir 500 mg Tabletsdrug
1 x 500 mg, single-dose fasting
Famvir® 500 mg Tabletsdrug
1 x 500 mg, single-dose fasting