Valacyclovir 1000 mg Tablet Under Fed Conditions
- Conditions
- Healthy
- Registration Number
- NCT01149460
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria<br><br> - Male or female, non-smokers, 18 years of age and older.<br><br> - Capable of consent<br><br>Exclusion Criteria<br><br>Subjects to whom any of the following applies will be excluded from the study:<br><br> - Clinically significant illnesses or surgery within 4 weeks of the administration of<br> study medication.<br><br> - Any clinically significant abnormality found during medical screening.<br><br> - Any reason which, in the opinion of the medical subinvestigator, would prevent the<br> subject from participating in the study.<br><br> - Abnormal laboratory tests judged clinically significant.<br><br> - Positive testing for hepatitis B, hepatitis C or HIV at screening.<br><br> - ECG abnormalities (clinically significant) or vital sign abnormalities (systolic<br> blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower<br> than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.<br><br> - BMI less than 19.0 or greater than or equal to 30.0 kg/m2.<br><br> - History of significant alcohol abuse within six months prior to the screening visit<br> (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine or 360 mL of<br> beer or 45 mL of alcohol 40% alcohol]) or positive urine drug screen at screening.<br><br> - History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)<br> within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine<br> (PCP) and crack) within 1 year prior to the screening visit or positive urine drug<br> screen at screening.<br><br> - History of allergic reactions to heparin, valacyclovir, acyclovir, or other related<br> drugs.<br><br> - Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of<br> inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole;<br> examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides,<br> imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30<br> days prior to the administration of the study medication.<br><br> - Use of an investigational drug or participation in an investigation study within 30<br> days prior to the administration of the study medication.<br><br> - Clinically significant history or presence of any clinically significant<br> gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases),<br> unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney<br> disease, or other conditions known to interfere with the absorption, distribution,<br> metabolism or excretion of the drug.<br><br> - Any clinically significant history or presence of clinically significant<br> neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic,<br> psychiatric or metabolic disease.<br><br> - Use of prescription medication within 14 days prior to administration of study<br> medication or over-the-counter products (including natural food supplements,<br> vitamins, garlic as a supplement) within 7 days prior to administration of study<br> medication, except for topical products without systemic absorption.<br><br> - Difficulty to swallow study medication.<br><br> - Use of any tobacco products in the 90 days preceding drug administration.<br><br> - Any food allergy, intolerance, restriction or special diet that, in the opinion of<br> the medical subinvestigator, could contraindicate the subjects participation in this<br> study.<br><br> - A depot injection or an implant of any drug within 3 months prior to administration<br> of study medication.<br><br> - Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or<br> loss of whole blood (excluding the volume of blood that will be drawn during the<br> screening procedures of this study) prior to administration of the study medication<br> as follows:<br><br> - 50 mL to 300 mL of whole blood within 30 days,<br><br> - 301 mL to 500 mL of whole blood within 45 days, or<br><br> - more than 500 mL of whole blood within 56 days prior to drug administration.<br><br> - Intolerance to venipunctures.<br><br> - Clinically significant history of renal, hepatic or cardiovascular disease,<br> tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible<br> for this study.<br><br> - Unable to understand or unwilling to sign the Informed Consent Form.<br><br> - Breast-feeding.<br><br> - Positive urine pregnancy test at screening.<br><br> - Female subjects of childbearing potential having unprotected sexual intercourse with<br> any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for<br> at least 6 months) within 14 days prior to study drug administration. Acceptable<br> methods of contraception:<br><br> - Intra-uterine contraceptive device (placed at least 4 weeks prior to study drug<br> administration),<br><br> - Condom or diaphragm + spermicide
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir;AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir;AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir
- Secondary Outcome Measures
Name Time Method Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir;AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir;AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir