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IRCT20220209053979N4 IRCT 2022-08-09 Sobhan Oncology A bioequivalence study of Niloitinib 150mg capsule of Sobhan Oncology compared to Tasigna 150 mg capsule manufactured by Novartis in 24 healthy volunteers under fasting condition A cross over bioequivalence study of Niloitinib 150mg capsule of Sobhan Oncology compared to Tasigna 150 mg capsule manufactured by Novartis in 24 healthy volunteers under fasting condition 2022-09-06 anticipated 24 Complete https://irct.ir/trial/64443 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: volunteers number 1-12 will be assigned code A and volunteers number 13-24 will be allocated code B. On the first phase, the first 12 candidates will be prescribed the test drug and the second 12 volunteers will receive the reference drug, and in the second phase, it is vise versa, that the first 12 volunteers who were given the test drug in the first phase will receive the reference drug and second group of volunteers who have received the reference drug in the first phase, will take the test drug. But non of the prescriber, volunteer, and the person analyzing the drug, know the difference between code A and B, and they do not know which medicine is prescribing, Blinding description: The drug (test or reference drug) is removed from the original packaging the day before the study and packaged in small disposable containers. Therefore, it is not in the original packaging and also the visual appearance and size of the test and reference capsules are the same , none of the volunteer nor the prescriber know which drug is being administered. The relevant code is also written on the sample collecting tubes of each volunteer, neither the analyzer knows the test or reference drug sample is analyzing. Bioequivalence Investigation of bioequivalence of Nilotinib 150 mg capsule manufactured by Sobbhan Oncology company in comparison to the Tagigna150 mg capsule manufactured by Novartis company. Intervention 1: Intervention group 1: Oral administration of a 150 mg capsule manufactured by Sobhan Oncology Company to 12 healthy volunteers in fasting condition with 240 ml of water. Then 14 blood samples are taken from volunteers at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 hours after drug administration. in the second phase after a wash out period of one week , this group take Novartis medicine and blood samples are taken at the same times. Intervention 2: Intervention group: Oral administration of a 150 mg capsule of Tasigna manufactured by Novartis Switzerland to 12 healthy volunteers in fasting condition with 240 ml of water. Then 14 blood samples are taken from each volunteers at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 hours. In the seconde phase after one week washout period they receive Sobhan Oncology drug and again at the same time they give a blood sample. 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, Islamshahr
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, Islamshahr
Islamshahr Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center Iran (Islamic Republic of) Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects Body mass index (BMI) >18 but <30. Laboratory parameter values must fall within the normal range 18 years 55 years Both Smokers History of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome. Other Treatment - Drugs Intervention group 1: Oral administration of a 150 mg capsule manufactured by Sobhan Oncology Company to 12 healthy volunteers in fasting condition with 240 ml of water. Then 14 blood samples are taken from volunteers at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 hours after drug administration. in the second phase after a wash out period of one week , this group take Novartis medicine and blood samples are taken at the same times Intervention group: Oral administration of a 150 mg capsule of Tasigna manufactured by Novartis Switzerland to 12 healthy volunteers in fasting condition with 240 ml of water. Then 14 blood samples are taken from each volunteers at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 hours. In the seconde phase after one week washout period they receive Sobhan Oncology drug and again at the same time they give a blood sample. Plasma concentration of Nilotinib of Sobhan Oncology and Tasigna manufactured by Novartis Company. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 h. Method of measurement: liquid chromatography mass spectrometry (LCMSMS). Sobhan Oncology Approved 2022-07-17 Research Ethics Committee of the Institute of Pharmaceutical Science 16 th Azar, Tehran University of medical science Tehran Tehran Iran (Islamic Republic of)