Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group: Prescription of ,400/60 mg Daclatasvir/Sofosbuvir Tablets manufactured by Rojan Pharmaceutical company. Intervention 2: Control group: Prescription of ,400/60
Sponsors
Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Written informed consent. Normal findings in the physical examination Clinical laboratory values within 10% above or below the laboratory’s stated normal range To be a non-smoker
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drug or related products Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the pharmacokinetics of the drug Any clinically significant illness during the 4 weeks prior to day 1 of this study Maintenance therapy with any drug, or history of drug dependence Alcohol abuse, or serious neurological or psychological disease Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study Positive test of HIV and Hepatitis A, B and C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration. Timepoint: 0 , 0.2 , 0.4 , 1 ,1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 4.5 , 5 , 6 , 8 , 12 , 24 , 48. Method of measurement: Lc MS MS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholamreza Bahrami
Kermanshah University of Medical Sciences
Outcome results
None listed