A cross over bioequivalence study of sunitinib 50 mg capsule of Sobhanoncology compared to Sutent 50 mg capsule manufactured by Pfizer in 24 healthy volunteers under fasting condition

Sobhan Oncology0 sites24 target enrollmentStarted: TBDLast updated: August 29, 2022

Conditions

Trial Snapshot

No summary available.

•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.

•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.

Sponsor

Sobhan Oncology