Health and normal volunteers.
Conditions
Sponsors
Zagrous Darou Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers Aged 18 to 45 years Based on laboratory safety tests no history of diseases affecting drug pharmacokinetic processes lack of any chronic or acute medication at least 1 week before the start of the study Actual weight (TBW) in the range of 20% IBW
Exclusion criteria
Exclusion criteria: Subject showed clinically relevant deviations from normal in physical examination Subject had undergone surgery of the gastrointestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day Use any medication within 14 days before the first treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: Blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour following drug administration. Method of measurement: Using High Performance Liquid Chromatography instrument. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0; 12.0; 16.0; 20.0; 24.0 hour post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Katayoun Derakhshandeh
Hamedan University of Medical Sciences
Outcome results
None listed