Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
This study has been completed.
Sponsor:
Sandoz Inc.
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00875966
First received: April 3, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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Purpose
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
| Condition | Intervention | Phase |
|---|---|---|
|
Infections |
Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sandoz:
Primary Outcome Measures:
- Bioequivalence based on AUC and Cmax [ Time Frame: 37 days ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | August 2004 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Azithromycin for oral suspension 200mg/5mL
|
Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC |
|
Active Comparator: 2
Zithromax (azithromycin for oral suspension) 200mg/5mL
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- No clinically significant findings on physical exam, medial history or laboratory tests on screening
Exclusion Criteria:
- Positive test for HIV or hepatitis B and C
- Treatment for Drug or alcohol abuse
- Any other important criteria in the protocol
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc. |
| ClinicalTrials.gov Identifier: | NCT00875966 History of Changes |
| Other Study ID Numbers: | AA17045 |
| Study First Received: | April 3, 2009 |
| Last Updated: | April 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013