Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866216
• Other study ID #: AA02511
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2009
• Last updated: March 27, 2017
• Start date: August 2003
• Est. completion date: September 2003

Study information

• Verified date: March 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

• Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		32 days