Healthy volunteers. Antiviral drugs
Conditions
Interventions
Intervention 1: Single dose ofone ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development Company. Intervention 2: Single dose of one Harvoni (ledipasvir/sofosbuvir)
Treatment - Drugs
Single dose ofone ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development Company
Single dose of one Harvoni (ledipasvir/sofosbuvir) 90/400 mg tablets manufactured by Gilead
Sponsors
Sobhan Medicine Trade Development Company
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to ledipasvir/sofosbuvir, or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. Presence of a medical condition requiring regular treatment with prescription drugs. 5. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 6. Receipt of any drug as part of a research study within 30 days prior to dosing. 7. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax). Timepoint: After intervention. Method of measurement: Blood sampling.;Area-under the curve (AUC) for plasma concentrations. Timepoint: After intervention. Method of measurement: Blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (Tmax). Timepoint: After intervention. Method of measurement: Blood sampling. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hossein Amini
Gorgan Bioanalysis Center
Outcome results
None listed