Trials / Completed
CompletedNCT00875966
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC | |
| DRUG | Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer | Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2004-10-01
- Completion
- 2004-10-01
- First posted
- 2009-04-06
- Last updated
- 2017-03-29
Source: ClinicalTrials.gov record NCT00875966. Inclusion in this directory is not an endorsement.