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Azithromycin 600 Mg Tablets, Fed

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Azithromycin 600 mg Tablet (Drug); Zithromax® 600 mg Tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Azber Ansar, M.D., Principal Investigator, Affiliation: Cetero Research, San Antonio

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.

Clinical Details

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 24 Fed, Healthy, Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration - Azithromycin in Plasma

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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:

- Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50

mmHg.

- 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.

Locations and Contacts

Gateway Medical Research, Inc., St. Charles, Missouri 63301, United States
Additional Information

Starting date: July 2002
Last updated: September 11, 2009

Page last updated: August 23, 2015

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