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Study aim:
Bioequivalence Study of Nilotinib 200mg capsule manufactured by Zistdaru Danesh company (Nitagxha) versus originator brand (Tasigna) manufactured by Novartis company
Design:
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct:
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is one week. In the first round of the study, the candidates divide into two groups. the first group receives a test capsule and the second group receives a brand capsule. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Nilotinib
Intervention groups:
Intervention group 1: Tasigna 200mg capsule as a reference Intervention group 2: Nitagxha 200mg as a test
Main outcome variables:
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug