Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals (Drug); Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc. (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s):
Alan S Marion, Principal Investigator, Affiliation: MDS Pharma
Summary
The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate
600 mg Tablets.
Clinical Details
Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Geneva 600mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- No clinically significant abnormal findings on physical exam, medical history, or
clinical laboratory results on screening
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C
- Treatment for drug or alcohol dependence
- Female subjects who are pregnant or lactating
Locations and Contacts
Additional Information
Starting date: August 2003
Last updated: March 19, 2009
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