Azithromycin 600 Mg Tablets, Fed

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834132
First received: January 30, 2009
Last updated: September 11, 2009
Last verified: September 2009
  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 24 adult subjects under fed conditions.


Condition Intervention Phase
Healthy
Drug: Azithromycin 600 mg Tablet
Drug: Zithromax® 600 mg Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration - Azithromycin in Plasma [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin
Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
Drug: Azithromycin 600 mg Tablet
1 x 600mg, single-dose fed
Active Comparator: Zithromax®
Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
Drug: Zithromax® 600 mg Tablet
1 x 600mg, single-dose fed

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.
    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834132

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Azber Ansar, M.D. Cetero Research, San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834132     History of Changes
Other Study ID Numbers: 02184
Study First Received: January 30, 2009
Results First Received: May 7, 2009
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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

ClinicalTrials.gov processed this record on September 18, 2014