Azithromycin 600 Mg Tablets, Fasting

NCT ID: NCT00834756

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2002-10-31

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 36 adult subjects under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Azithromycin

Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period

Group Type: EXPERIMENTAL

Azithromycin 600 mg Tablet

Intervention Type: DRUG

1 x 600mg, single-dose fasting

Zithromax®

Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

Zithromax® 600 mg Tablet

Intervention Type: DRUG

1 x 600mg, single-dose fasting

Interventions

Azithromycin 600 mg Tablet

1 x 600mg, single-dose fasting

Intervention Type: DRUG

Zithromax® 600 mg Tablet

1 x 600mg, single-dose fasting

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sex:Non-smoking Male or Female; similar proportions of each preferred.
• Age: At least 18 years.
• Weight: BMI less than 30.
• 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.

• 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:

• 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.

• Inability to read and/or sign the consent form.
• Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
• Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
• Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) At least three (4) consecutive months of abstinence is required.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Steven Herrmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

02183

Identifier Type: -

Identifier Source: org_study_id