CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
Zithromax® +1 moredrug
Likely dose
200 mg/5 mL azithromycin oral suspensionAI-extracted
Key inclusion· 4
  • ✓Healthy men and women 18 years of age or older at time of dosing
  • ✓Body mass index (BMI) between 19 and 30
  • ✓Screening completed within 28 days prior to dosing
  • ✓Female subjects must be postmenopausal for ≥1 year, surgically sterile, or using acceptable contraception
Key exclusion· 10
  • ✕Recent history of drug or alcohol addiction or abuse
  • ✕Clinically significant disorder involving cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems or psychiatric disease
  • ✕Abnormal clinical laboratory values deemed clinically significant on re-examination
  • ✕Reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00830206
NCT00830206Phase 1Completed
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A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Jan 27, 2009·Updated Aug 20, 2024

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®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2009
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Azithromycinother

Oral Suspension

Zithromax®drug

Oral Suspension