An open label randomized, single dose, three-way, partial replicate bioequivalence study to determine the bioequivalence of Solifenacin Succinate \& Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg Film Coated Tablets \& Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 30 Healthy volunteers (28 volunteers + 2 extra volunteers to compensate for drop-outs) will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report. For Solifenacin: Primary Pharmacokinetic Parameters: Cmax and truncated AUC0→72 Secondary Pharmacokinetic Parameters: Tmax For Mirabegron: Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for log transformed (with the 90% confidence intervals), untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e, for Mirabegron and untransformed data of Cmax and truncated AUC0→t and for untransformed data of tmax for Solifenacin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water
1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water
1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water
Genuine Research Center GRC
Cairo, Egypt
For Solifenacin: Cmax
to measure the maximal measured plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
For Solifenacin: truncated AUC0→72
to measure truncated area under the curve from zero time to 72 hours
Time frame: Up to 72 hours post dose in each treatment period
For Mirabegron: Cmax
to measure the maximal measured plasma concentration
Time frame: Up to 240 hours post dose in each treatment period
For Mirabegron: AUC0→t
to measure the area under the curve from zero time to 240 hours
Time frame: Up to 240 hours post dose in each treatment period
For Mirabegron: AUC0→∞
to measure the area under the curve from zero time to infinity
Time frame: Up to 240 hours post dose in each treatment period
For Solifenacin & Mirabegron: Tmax
Time of the maximum plasma concentration
Time frame: For Solifenacin:Up to 72 hours post dose in each treatment period & For Mirabegron:Up to 240 hours post dose in each treatment period
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