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Study aim:
In-vivo bioequivalence study of Itraconazole 100 mg capsule of the test drug manufactured by Arian Salamat Sina pharmacutical company in compared with the reference drug Sporanox 100 mg capsule
Design:
Bioequivalence study, Cross-over design, Single dose, Single-blinded, 24 healthy volunteers, Two period, two week wash out period, Simple randomization method will be used.
Settings and conduct:
This single-blind, two-period crossover study was conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 72hours, with a two -week washout interval between them. In the first period, based on computer-generated randomization, Group 1 received the reference drug while Group 2 received the test drug. In the second period, the treatments were switched. The study was single-blinded, meaning that participants were unaware whether they received the test or reference drug during either sampling period.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: No history of heart, kidney & liver disease. The ages and BMIs of participant should be in the range of 18-55 and 18-30 respectively. Exclusion criteria: Smoking, Alcohol and drug addiction, History of allergy to drug, Pregnancy.
Intervention groups:
Intervention group one receivesItraconazole 100 mg capsule of the test drug manufactured by Arian Salamat Sina pharmacutical company in the first round, and in the second round, after two-week washout period, the drug Sporanox 100 mg . Intervention group No.2 receives the drugs in the switched order.
Main outcome variables:
The concentration of the drug in blood, Time to reach maximum blood concentration, Extent of absorption