Back to resultsTo Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
Primary Purpose
Infection
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin Monohydrate 600 mg Tablets
Zithromax (azithromycin dihydrate) 600 mg Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Infection
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal finding 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Azithromycin Monohydrate 600mg Tablets
Zithromax (azithromycin dihydrate)600mg Tablets
Outcomes
Primary Outcome Measures
Bioequivalence according to US FDA guidelines
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00865670
Brief Title
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
Official Title
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Azithromycin Monohydrate 600mg Tablets
Arm Title
2
Arm Type
Active Comparator
Arm Description
Zithromax (azithromycin dihydrate)600mg Tablets
Intervention Type
Drug
Intervention Name(s)
Azithromycin Monohydrate 600 mg Tablets
Intervention Type
Drug
Intervention Name(s)
Zithromax (azithromycin dihydrate) 600 mg Tablets
Primary Outcome Measure Information:
Title
Bioequivalence according to US FDA guidelines
Time Frame
32 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Marion, M.D.
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
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