Mycophenolate Mofetil Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Mycophenolate Mofetil; CellCept® Tablets
Intervention description: Mycophenolate Mofetil Tablet 500 mg; CellCept® Tablets, 500 mg
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Subjects

Summary:

      The objective of this study was to evaluate the comparative bioavailability between
      Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a
      single-dose in healthy subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, non-smoking male subjects, 18 years of age or older.

          -  Healthy, non-smoking post-menopausal or surgically sterile females 18 years of age or
             older.

          -  BMI ≥ 19 and ≤ 30.

          -  Negative for:

               1. HIV.

               2. Hepatitis B surface antigen and Hepatitis C antibody.

               3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine,
                  opiates, benzodiazepines and methadone).

               4. Urine cotinine test

               5. Serum HCG consistent with pregnancy (females only)

          -  No significant diseases or clinically significant findings in a physical examination.

          -  No clinically significant abnormal laboratory values.

          -  No clinically significant findings in vital signs measurements and a 12-lead
             electrocardiogram (ECG).

          -  Be informed of the nature of the study and given written consent prior to receiving
             any study procedure.

          -  Females who participate in this study must be unable to have children:

               1. post-menopausal for at least 1 year - no menstrual cycle for 12 months and LH and
                  FSH levels judged by a physician to be consistent with post-menopausal status.

                  OR

               2. Proof of surgical sterility.

          -  Females who participate in this study are not pregnant and/or non-lactating.

        Exclusion Criteria:

          -  Known history or presence of any clinically significant medical condition.

          -  Known or suspected carcinoma.

          -  Known or suspected increased susceptibility to infection.

          -  Known history or presence of active tuberculosis (TB).

          -  Results of a previous TB skin test greater than 5 mm in diameter.

          -  Lived in or traveled, during the last 8 weeks, to a country defined by the Public
             Health Agency of Canada as having WHO estimated sputum smear positive pulmonary TB
             rate of 15 per 100,000 or higher.

          -  Known history or presence of:

               1. Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any
                  other drug substances with similar activity.

               2. Alcoholism within the last 12 months.

               3. Drug dependence and/or substance abuse.

               4. Use of tobacco or nicotine-containing products within the last 6 months.

          -  On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein,
             raw food diet).

          -  Participated in another clinical trial or received and investigational product within
             30 days prior to drug administration.

          -  Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499
             mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the
             previous 56 days (based on the Canadian Blood Services guideline for blood donation.

          -  Females taking oral or transdermal hormonal contraceptives within 14 days preceding
             period 1 dosing.

          -  Females having taken implanted or injected hormonal contraceptives within 6 months
             prior to period 1 dosing.

          -  Requirement of any non-topical medication (prescription and/or over-the-counter) on a
             routine basis.

          -  Difficulty fasting or consuming the standard meals.

          -  Do not tolerate venipuncture.

          -  Unable to read or sign the ICF.