Valacyclovir 1000 mg Tablet Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Valacyclovir; Valacyclovir
Intervention description: Test 1000 mg Tablet; Reference Listed Valacyclovir 1000 mg Tablet
Intervention MeSH terms: Valacyclovir
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

Summary:

      The objective of this study was to compare the rate and extent of absorption of Teva
      Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir,
      administered as 1 x 1000 mg tablet under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female, non-smokers, 18 years of age and older.

          -  Capable of consent

        Exclusion Criteria

        Subjects to whom any of the following applies will be excluded from the study:

          -  Clinically significant illnesses or surgery within 4 weeks of the administration of
             study medication.

          -  Any clinically significant abnormality found during medical screening.

          -  Any reason which, in the opinion of the medical subinvestigator, would prevent the
             subject from participating in the study.

          -  Abnormal laboratory tests judged clinically significant.

          -  Positive testing for hepatitis B, hepatitis C or HIV at screening.

          -  ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood
             pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or
             over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.

          -  BMI less than 19.0 or greater than or equal to 30.0 kg/m2.

          -  History of significant alcohol abuse within six months prior to the screening visit
             (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine or 360 mL of
             beer or 45 mL of alcohol 40% alcohol]) or positive urine drug screen at screening.

          -  History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)
             within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine
             (PCP) and crack) within 1 year prior to the screening visit or positive urine drug
             screen at screening.

          -  History of allergic reactions to heparin, valacyclovir, acyclovir, or other related
             drugs.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of
             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole;
             examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides,
             imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days
             prior to the administration of the study medication.

          -  Use of an investigational drug or participation in an investigation study within 30
             days prior to the administration of the study medication.

          -  Clinically significant history or presence of any clinically significant
             gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases),
             unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney
             disease, or other conditions known to interfere with the absorption, distribution,
             metabolism or excretion of the drug.

          -  Any clinically significant history or presence of clinically significant neurological,
             endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or
             metabolic disease.

          -  Use of prescription medication within 14 days prior to administration of study
             medication or over-the-counter products (including natural food supplements, vitamins,
             garlic as a supplement) within 7 days prior to administration of study medication,
             except for topical products without systemic absorption.

          -  Difficulty to swallow study medication.

          -  Use of any tobacco products in the 90 days preceding drug administration.

          -  Any food allergy, intolerance, restriction or special diet that, in the opinion of the
             medical subinvestigator, could contraindicate the subjects participation in this
             study.

          -  A depot injection or an implant of any drug within 3 months prior to administration of
             study medication.

          -  Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or
             loss of whole blood (excluding the volume of blood that will be drawn during the
             screening procedures of this study) prior to administration of the study medication as
             follows:

          -  50 mL to 300 mL of whole blood within 30 days,

          -  301 mL to 500 mL of whole blood within 45 days, or

          -  more than 500 mL of whole blood within 56 days prior to drug administration.

          -  Intolerance to venipunctures.

          -  Clinically significant history of renal, hepatic or cardiovascular disease,
             tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible
             for this study.

          -  Unable to understand or unwilling to sign the Informed Consent Form.

          -  Breast-feeding.

          -  Positive urine pregnancy test at screening.

          -  Female subjects of childbearing potential having unprotected sexual intercourse with
             any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for
             at least 6 months) within 14 days prior to study drug administration. Acceptable
             methods of contraception:

          -  Intra-uterine contraceptive device (placed at least 4 weeks prior to study drug
             administration),

          -  Condom or diaphragm + spermicide