Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Clarithromycin ER 500 mg tablets; BIAXIN® XL 500 mg tablets
Intervention description: 1 x 500 mg; 1 x 500 mg
Intervention MeSH terms: Clarithromycin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the relative bioequivalence of a test
      clarithromycin extended release formulation to an equivalent oral dose of the commercially
      available extended release clarithromycin in a test population of 66 adult subjects under
      fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Sex: Males or females who are surgically sterile or have been post-menopausal for at
             least 6 months; similar proportions of each preferred.

          -  Age: At least 18 years.

          -  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 subjects 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:

               1. Laboratory Tests:

                  Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Nz, K,
                  Cl), fasting blood glucose, BUN, bilirubin,m 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. Post-menopausal females will have an FSH (Follicle Stimulating Hormone)
                  level performed to confirm post-menopausal status.

                  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.

               2. 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:

               1. History of treatment for alcoholism, substance abuse, or drug abuse within past
                  24 months.

               2. History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or
                  other serious illness.

               3. History of treatment for any gastrointestinal disorder within the past 5 years.

               4. History of treatment for asthma within the past five (5) years.

               5. History of diarrhea within 24 hours prior to dosing.

               6. Females who are pregnant or lactating.

               7. History of hypersensitivity to clarithromycin or any macrolide antibiotic.

        C. Conditions upon screening which might contraindicate or require that caution be used in
        the administration of dexmethylphenidate hydrochloride, including:

          1. Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.

          2. 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.). Three (3) consecutive months abstinence is
                  required.