Bioequivalence study of valacyclovir 1000 mg tablet
Not Applicable
- Conditions
- Bioequivalence study of valacyclovir 1000 mg tablet (Iran Hormone) versus VALTREX ® 1000 mg (GlaxoSmithKline) Tablet in healthy volunteers.
- Registration Number
- IRCT20220111053692N2
- Lead Sponsor
- Iran Hormone pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
18 to 55 years old
Weight in range of 10 % proper body weight
All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test.
and possessing negative test for hepatitis B surface antigen (HBs-Ag), antihepatitis-C antibody (anti-HCV), and anti-HIV.
just man
Exclusion Criteria
Volunteers with hypersensitivity to valacyclovir were excluded.
those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with valacyclovir until one month before studying.
disinclination to take the test
Blood donation or blood loss of more than 200 ml in the past month
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma samples. Timepoint: In times 0, 0/25, 0/5, 0/75, 1, 1/25, 1/5, 1/75, 2, 2/5, 3, 4, 6, 8, 10, 24, 30 Hours after the start of the intervention. Method of measurement: chromatography.
- Secondary Outcome Measures
Name Time Method