At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Azithromycin 600 mg Tablet +1 moredrug
Likely dose
Azithromycin 600 mg Tabletfrom 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 Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 36 Fasted, Healthy, Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Azithromycin 600 mg Tablet and Zithromax® 600 mg Tablet for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 36 adult subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2002
Primary CompletionOct 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartSep 1, 2002
Primary CompletionOct 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Azithromycin 600 mg Tabletdrug
1 x 600mg, single-dose fasting
Zithromax® 600 mg Tabletdrug
1 x 600mg, single-dose fasting