A bioequivalence study of Sunitinib 50 mg capsules of Sobhanoncology compared to Sutent 50 mg Capsule manufactured by Pfizer in 24 healthy volunteers under fasting conditio

Not Applicable

Conditions: Bioequivalence study.

Registration Number: IRCT20220209053979N3

Lead Sponsor: Sobhan Oncology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 24

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures