Azithromycin 600 Mg Tablets, Fed
Condition: Healthy
Intervention: Azithromycin 600 mg Tablet; Zithromax® 600 mg Tablet
Intervention description: 1 x 600mg, single-dose fed; 1 x 600mg, single-dose fed
Intervention MeSH terms: Azithromycin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

Eligibility 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.