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Azithromycin 600 Mg Tablets, Fasting
This study has been completed.
First Received: January 30, 2009   Last Updated: February 2, 2009   History of Changes
Sponsored by: Teva Pharmaceuticals USA
Information provided by: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00834756
  Purpose

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

Drug Information available for: Azithromycin
U.S. FDA Resources
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

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834756

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
United States, Texas
CEDRA Corporation
Austin, Texas, United States, 78754
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Steven Herrmann, M.D. Cetero Research
  More Information

No publications provided

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

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Study placed in the following topic categories:
Anti-Bacterial Agents
Azithromycin
Healthy

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Azithromycin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009