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

Comparison of the bioavailability of Nilotinib capsules after a single dose of 150 mg, manufactured by Soban Ancology and Novartis .

The study is a cross-over double-blind study. 24 healthy volunteers using the random option in excel software will be assigned a code, and depending on the code, the first half will receive the test, and the second half will receive reference drugs. In each phase of the study, 14 blood samples will be received from the individual.

On the day of sampling, after 10 hours of fasting, the volunteers come to Kharazmi Plasma Center in Islamshahr ( No. 13, 1st Shehamat Alley, Ali Ibn Abitalib St., Namaz Square,) and receive one capsule of the test or reference drug with 240 ml of water and blood samples are taken at 0.5,1,1.5,2,2.5, 3, 3.5,4,6,8,10,24,32,48 hours after drug administration, after plasma separation, the samples were transferred to a -70 freezer and finally the concentration of drug in plasma will be determined according to the LCMSMS method.After a one-week wash out period, the process of drug administration is done vise versa.

Inclusion criteria: Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects, Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.Laboratory parameter values must fall within the normal range Exclusion criteria: Contraindication to receiving nilotinib. Smokers or user of tobacco products , A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Comparing the blood concentration of nilotinib from Soban Oncology company with Novartis company sample

Plasma concentration caused by test and reference drug

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.

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.

The study is confidential and must be allowed by Sobhan Oncology for publication