NCT05767632

Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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)

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)	1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water
DRUG	Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)	1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water
DRUG	Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)	1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-07-25
• Completion: 2022-10-25
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

1 site across 1 country: Egypt