None listed
Conditions
Interventions
Intervention 1: Intervention group 1: Oral administration of a single 50 mg dose of sildenafil (1 tablet) manufactured by ParsDarou to healthy volunteers under fasting condition in the morning of the
Sponsors
ParsDarou Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 18-55 years of age The subject is able and willing to provide signed informed consent Willing to adhere to protocol requirements as evidenced by written informed consent The subject has a stable residence and telephone Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
Exclusion criteria
Exclusion criteria: History of allergy or sensitivity to sildenafil History of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject of the study Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction Presence of gastrointestinal disease or history of malabsorption within the last year History of a medical disorders occurring within the last year that required hospitalization or medication Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing Receipt of any drug as part of a research study within 30 days prior to the present study Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma drug concentration. Timepoint: At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography.;Area under plasma concentration-time curve. Timepoint: At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax. Timepoint: At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography.;Plasma half-life. Timepoint: By using concentration at time points of 5, 6, 8, 10 and 12. Method of measurement: Blood sampling and drug analysis by high-performance liquid chromatography method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Amini
Gorgan University of Medical Sciences
Outcome results
None listed