At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
200 mg/5 mL azithromycin oral suspensionAI-extracted
Key inclusion· 3
- ✓Healthy men and women 18 years of age or older
- ✓Body mass index (BMI) between 19 and 30
- ✓Screening completed within 28 days prior to dosing
Key exclusion· 16
- ✕History of drug or alcohol addiction or abuse
- ✕Clinically significant disorder of cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, neurologic, or psychiatric systems
- ✕Positive screen for hepatitis B, hepatitis C, or HIV
- ✕Positive drug abuse screen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Azithromycin and Zithromax® for Healthy. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
Primary CompletionNov 2005
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartOct 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Azithromycindrug
Oral Suspension
Zithromax®drug
Oral Suspension