Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group: Oral administration of a 50 mg sunitinib capsule made by Sobhan Oncology Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood sampl
Sponsors
Sobhan Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: No signs of acute or chronic disease during the screening. Non-smokers No known history of drugs abuse at least 6 months prior to being included in the test Volunteer's consent to use two medically effective methods of contraception, at least one of which is a barrier method (from the date of screening to the completion of the study and within 10 weeks after the last dose of drugs) The subject's voluntary willingness to sign written informed consent.
Exclusion criteria
Exclusion criteria: Burdened allergic history Use of any over-the-counter or prescription drugs (including vitamins, minerals, herbal drugs, in particular containing tutsan), use of any dietary supplements less than 14 days before the day of taking the study drug, and throughout the study Participation in any clinical studies less than 90 days prior to the beginning of the current clinical study. Any blood/plasma donation and/or bleeding in the amount of 450 ml, as well as if the volunteers were transfused with whole blood or its components less than 60 days before the start of the study. Subjects with abnormal heart rhythm (HR at rest = 100 bpm or = 50 bpm) and BP (systolic BP =100 mmHg or diastolic BP =60 mmHg or systolic BP =140 mm Hg or diastolic BP = 90 mmHg) on the day of the examination or in the history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Sunitinib 50 mg of Sobhan Oncology and Sutent manufactured by Pfizer Company. Timepoint: 0, 1, 2, 3, 4, 5, 6, , 8, 9, 10, 11, 12, 24, 36, 48 , 72 hours after drug administration. Method of measurement: liquid chromatography mass spectrometry (LCMSMS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Talari
Kharazmi Plasma Center
Outcome results
None listed