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 24 Fed, Healthy, Adult Subjects

Teva Pharmaceuticals USA1 site in 1 country24 target enrollmentJuly 2002

ConditionsHealthy

InterventionsAzithromycin 600 mg Tablet Zithromax® 600 mg Tablet

DrugsAzithromycin 600 mg Tablet Zithromax® 600 mg Tablet

Overview

Phase: Phase 1
Intervention: Azithromycin 600 mg Tablet
Conditions: Healthy
Sponsor: Teva Pharmaceuticals USA
Enrollment: 24
Locations: 1
Primary Endpoint: Cmax - Maximum Observed Concentration - Azithromycin in Plasma
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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 24 adult subjects under fed conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

August 2002

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Teva Pharmaceuticals USA

Eligibility Criteria

Inclusion Criteria

•Sex:Non-smoking Male or Female; similar proportions of each preferred.
•Age: At least 18 years.
•Weight: BMI less than
•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:
•Laboratory Tests: hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in. Laboratory values which are greater than ± 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
•Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
•Subjects must read and sign the Consent Form.

Exclusion Criteria

•Subjects not complying with the above inclusion criteria must be excluded from the study.
•In addition, any one of the conditions listed below will exclude a subject from the study:
•History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
•History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
•History of treatment for asthma within the past five (5) years.
•History of treatment for any gastrointestinal disorder within the past five (5) years.
•History of hepatic function impairment.
•Females who are pregnant or lactating.
•History of hypersensitivity to azithromycin, erythromycin, or any macrolide antibacterial agent.
•Conditions upon screening which might contraindicate or require that caution be used in the administration of azithromycin, including: