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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830336 |
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 oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Azithromycin |
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 Non-Fasting Conditions |
Enrollment: | 80 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2005 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Azithromycin for Oral Suspension 200 mg/5 mL
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Drug: Azithromycin |
2: Active Comparator
Zithromax® for Oral Suspension 200 mg/5 mL
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Drug: Azithromycin |
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:
United States, North Dakota | |
PRACS Institute Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute, Ltd. |
Study ID Numbers: | R05-1375 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830336 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Anti-Bacterial Agents Azithromycin Healthy |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Azithromycin Pharmacologic Actions |