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A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00830206
First received: January 26, 2009
Last updated: September 1, 2009
Last verified: September 2009

January 26, 2009
September 1, 2009
January 2006
January 2006   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration [ 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) [ 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) [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00830206 on ClinicalTrials.gov Archive Site
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A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX®.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Other: Azithromycin
    Oral Suspension
  • Drug: Zithromax®
    Oral Suspension
  • Experimental: Azithromycin (test)
    Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
    Intervention: Other: Azithromycin
  • Active Comparator: Zithromax® (reference)
    Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
    Intervention: Drug: Zithromax®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30.
  • Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing.
  • Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
  • Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
  • The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
  • The screening clinical laboratory procedures will include:

    • HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
    • CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
    • HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens
    • URINALYSIS: by dipstick; full microscopic examination if dipstick positive
    • URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
    • SERUM PREGNANCY SCREEN (female subjects only)
  • If female and:

    • Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
    • Is postmenopausal for at least 1 year; or
    • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria

  • Subjects with a recent history of drug or alcohol addiction or abuse.
  • Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
  • Subjects demonstrating a positive drug abuse screen when screened for this study.
  • Female subjects demonstrating a positive pregnancy screen.
  • Female subjects who are currently breastfeeding.
  • Subjects with a history of allergic response(s) to azithromycin or related drugs.
  • Subjects with a history of clinically significant allergies including drug allergies.
  • Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
  • Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  • Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
  • Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
  • Subjects who report an intolerance of direct venipuncture.
  • Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
  • Female subjects who report using implanted or injected hormonal contraceptives (birth control) during the 6 months prior to Period I dosing.
  • Female subjects who report using oral hormonal contraceptives (birth control) during the 14 days prior to Period I dosing.
  • Subjects who report having difficulty fasting or consuming standardized meals.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830206
R05-1430
No
Vice President Global Generic Biopharmaceutics, TEVA Pharmaceuticals USA
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute, Ltd.
Teva Pharmaceuticals USA
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP