Famciclovir 500 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Famciclovir 500 mg Tablets; Famvir® 500 mg Tablets
Intervention description: 1 x 500 mg, single-dose fasting; 1 x 500 mg, single-dose fasting
Intervention MeSH terms: Famciclovir
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
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 bioavailability of famciclovir 500 mg
      tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult
      subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects selected for this study will be at least 18 years of age.

          -  Each subject shall be given a general physical examination within 28 days of
             initiation of the study. Such examination includes, but is not limited to, blood
             pressure, general observations, and history.

          -  Each female subject will be give a serum pregnancy test as part of the pre-screening
             process.

          -  Adequate blood and urine samples should be obtained within 28 days before beginning of
             the first period and at the end of the trial for clinical laboratory measurements.

        Clinical laboratory measurements will include the following:

          -  Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood
             cell count (with differential).

          -  Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and
             alkaline phosphatase.

          -  Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult
             blood, and cells.

          -  HIV Screen: pre-study only.

          -  Hepatitis-B, C Screen: pre-study only.

          -  Drugs of Abuse Screen: pre-study and at check-in each study period.

        Electrocardiograms of all participating subjects will be recorded before initiation of the
        study and filed with each subject's case report forms.

        Exclusion Criteria:

          -  Subjects with a history of alcoholism or drug addiction (during past 2 years), or
             serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis,
             epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be
             eligible for this study.

          -  Subjects whose clinical laboratory test values are outside the normal range may be
             retested at the discretion of the clinical investigator. If the clinical values are
             outside the range on retesting, the subject will not be eligible to participate in the
             study unless the clinical investigator deems the result to not be significant.

          -  Subjects who have a history of allergic responses to the class of drug being tested
             should be excluded form the study.

          -  All subjects will have urine samples assayed for the presence of drugs of abuse as
             part of the clinical laboratory screening procedures and at each check-in. Subjects
             found to have urine concentrations of any of the tested drugs will not be allowed to
             participate.

          -  Subjects should not have donated blood and/or plasma for at least thirty (30) days
             prior to the first dosing of the study.

          -  Subjects who have taken any investigational drug within thirty (30) days prior to the
             first dosing of the study will not be allowed to participate.

          -  Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant
             during the study will not be allowed to participate. Female subjects of child bearing
             potential must either abstain from sexual intercourse or use a reliable barrier method
             (e.g. condom, IUD) of contraception during the course of the study (first dosing until
             last blood collection) or they will not be allowed to participate. Subjects who have
             used implanted or injected hormonal contraceptives anytime during the 6 months prior
             to study dosing, or used oral hormonal contraceptives within 14 days before dosing
             will not be allowed to participate.

          -  All female subjects will be screened for pregnancy at check-in each study period.
             Subjects with positive or inconclusive results will be withdrawn from the study.