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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834756 |
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 36 adult subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Azithromycin 600 mg Tablet Drug: Zithromax® 600 mg Tablet |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 36 Fasted, Healthy, Adult Subjects |
Enrollment: | 36 |
Study Start Date: | September 2002 |
Study Completion Date: | October 2002 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Azithromycin 600 mg Tablet
1 x 600mg, single-dose fasting
|
2: Active Comparator |
Drug: Zithromax® 600 mg Tablet
1 x 600mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
Exclusion Criteria:
In addition, any one of the conditions listed below will exclude a subject from the study:
Conditions upon screening which might contraindicate or require that caution be used in the administration of azithromycin, including:
* Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50 mmHg.
b. Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
United States, Missouri | |
Gateway Medical Research, Inc. | |
St. Charles, Missouri, United States, 63301 | |
United States, Texas | |
CEDRA Corporation | |
Austin, Texas, United States, 78754 |
Principal Investigator: | Steven Herrmann, M.D. | Cetero Research |
Study ID Numbers: | 02183 |
Study First Received: | January 30, 2009 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00834756 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 |