A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
Condition: Healthy
Intervention: Azithromycin; Zithromax®
Intervention description: Oral Suspension; Oral Suspension
Intervention MeSH terms: Azithromycin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      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 oral suspension
      distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400
      mg) in healthy adult subjects administered under non-fasting conditions.
    

Eligibility criteria:

        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.