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IRCT20220209053979N3 IRCT 2022-08-08 Sobhan Oncology 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 condition 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 2022-07-21 anticipated 24 Complete https://irct.ir/trial/64417 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Blinding description: The drug (test or reference drug) is removed from the original packaging the day before the study and packed in small disposable containers. Therefore, because it is not in the original packaging, the volunteer and the prescriber do not know which drug is being administered to volunteer. Each volunteeris also assigned a code that, depending on the code, half of them receive the test drug in the first phase and the other half receive the reference drug, and then in the second phase, vice versa, the group that took the test drug in the first phase in the second phase will receive reference drug. And the group that received the reference medicine takes the test medicine. Bioequivalence Bioequivalence study. 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 samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Pfizer's drug in and give a blood sample at the above times. Intervention 2: Intervention group: Oral administration of a 50 mg sunitinib capsule made by Pfizer Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Sunitinib of Sobhan Oncology in and give a blood sample at the above times. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study is confidential and must be allowed by Sobhan Oncology for publication
public Roya Talari
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Namaz Sq.,
Islamshahr Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center scientific Roya Talari
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Namaz Sq.
Islamshahr Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center Iran (Islamic Republic of) 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. 18 years 55 years Both 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. Treatment - Drugs Treatment - Drugs 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 samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Pfizer's drug in and give a blood sample at the above times Intervention group: Oral administration of a 50 mg sunitinib capsule made by Pfizer Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Sunitinib of Sobhan Oncology in and give a blood sample at the above times 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). Sobhan Oncology Approved 2022-07-13 Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences 16 Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)