Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830206 |
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX®.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Other: Azithromycin Drug: Zithromax® |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions |
Enrollment: | 80 |
Study Start Date: | January 2006 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Azithromycin (test): Experimental
Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
|
Other: Azithromycin
Oral Suspension
|
Zithromax® (reference): Active Comparator
Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
|
Drug: Zithromax®
Oral Suspension
|
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute, Ltd. |
Responsible Party: | TEVA Pharmaceuticals USA ( Vice President Global Generic Biopharmaceutics ) |
Study ID Numbers: | R05-1430 |
Study First Received: | January 26, 2009 |
Results First Received: | June 18, 2009 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00830206 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Anti-Infective Agents Anti-Bacterial Agents Azithromycin Healthy |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Azithromycin Pharmacologic Actions |