This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablets Valtrex 1000 mg, ) as a reference product. after washout period, the volunteers received Valacyclovir 1000 mg (,Tadbir Kalaye jam phar
Sponsors
Tadbir Kala Jam
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-55years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Valacyclovir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0? 0/25? 0/5? 0/75? 1?1/25? 1/5? 1/75? 2? 2/5? 3? 4? 6? 8? 10, 24h after drug administration. Method of measurement: Liquid chromatography–mass spectrometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Ali Karkhaneh Yousefi
Tadbir Kalaye Jam co.
Outcome results
None listed