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Study aim:
Examining the bioequivalency of domestically produced Mirabegron Extended-Release tablets formulations with brand name ®Betmiga
Design:
A cross over, not blinded, randomized, bioequivalence clinical trial on 24 healthy volunteers.
Settings and conduct:
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. The number of 24 volunteers in the age range of 18-55 years and the Body Mass Index range of 18-30, who are voluntarily selected through public notification. One extended-release tablet is taken fasting and blood is taken at 15 time points. Two weeks later, the process is repeated for the brand medicine.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: The weight range of 60-100 kg; being a non-smoker; being healthy in terms of physical examination, ECG, and the laboratory tests; Volunteers who have agreed to an informed consent form. Exclusion criteria: History of allergic or adverse reaction to Mirabegron or any similar product; blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg; Individuals who have donated whole blood during the previous 2 months of the study or donated blood components within 2 weeks before taking the first dose of the drug.
Intervention groups:
Intervention group 1: Mirabegron Extended-Release tablets manufactured by Faran Shimi Pharmaceutical Company is the test product. Intervention group 2: Betmiga® tablets manufactured by Astellas Company is the reference product. In each period, 12 of 24 subjects will be given single dose of this product and for up to 72 hours, 3 ml of blood will be collected from the volunteer at 15 time points each time. After the washout period (Two weeks), the volunteers are placed in the opposite group
Main outcome variables:
Plasma concentration of the drug