An open label randomized, single dose, three way three sequence two treatment partial replicate crossover study to determine the bioequivalence of Mirabegron from Bladogra 50 mg Extended Release film coated tablets (Man by Multi-Apex for pharmaceutical Industries -S.A.E for Apex pharma company, Egypt) and Myrbetriq 50 mg Extended Release tablets (Marketed by Astellas Pharma US, Inc, Product of Japan) after a single oral dose administration of each to healthy adults under fasting conditions.
Primary Pharmacokinetic Parameters: Cmax, Truncated AUC0→t Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, Truncated AUC0→t and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, Truncated AUC0→t to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
29
1 tablet contains 25 mg Mirabegron
1 tablet contains 25 mg Mirabegron
1 tablet contains 25 mg Mirabegron
Genuine Research Center GRC
Cairo, Egypt
Cmax
Maximal measured plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Time frame: Up to 72 hours post dose in each treatment period
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