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.
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
