This study is conducted on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: SANDOSTATIN® 20 mg injectable solution manufactured by Novartis as a reference drug, 12 volunteers, the first group, will receive a 20 mg single dose of this drug a
Sponsors
Homa Pharmed Pharmaceutical company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent form Age between18-55
Exclusion criteria
Exclusion criteria: Smoking Pregnancy Having a hypersensitivity to the drug Having a Alcohol & Drug addiction Having a history of cardiovascular disease Having a history of liver & kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 0 , 0.33 , 0.66 , 1 , 1.5 , 2 , 2.5 , 3 , 4, 6, 8, 10, 12, 24h after drug administration, and 2, 4, 6 ,7, 8, 10, 14, 18, 22, 28, 35, 42, 56 day after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed