Phase 1Completed
Bioequivalence Study of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)
An Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study to Determine the Bioequivalence of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan) in Healthy Human Volunteers Under Fasting Condition.
- Sponsor
- Genuine Research Center, Egypt (Industry)
- Enrollment
- 29 enrolled
- Conditions
- Healthy
- Interventions
- Bladogra; Myrbetriq (first dosing); Myrbetriq (second dosing)
- Ages
- adults
- Registry
- NCT04476966
Full record on ClinicalTrials.gov
From the registry
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 outcomes
- Cmax
History
Last registry update
Registered
Study completion
Primary completion
Started