At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Cefadroxil 500 mg Capsules +1 moredrug
Likely dose
Cefadroxil 500 mg Capsulesfrom 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 Two-Way , Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefadroxil 500 mg Capsules Versus DURICEF® 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
In Brief
A Phase 1 clinical trial evaluating Cefadroxil 500 mg Capsules and DURICEF® capsules 500 mg for Healthy. Completed, enrolled 26 participants across 2 sites in 2 countries.
Detailed Summary
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
Primary CompletionOct 2004
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartSep 1, 2004
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Cefadroxil 500 mg Capsulesdrug
1 x 500 mg
DURICEF® capsules 500 mgdrug
1 x 500 mg