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.

Genuine Research Center, Egypt1 site in 1 country29 target enrollmentJanuary 20, 2020

ConditionsHealthy

InterventionsBladogra Myrbetriq (first dosing)Myrbetriq (second dosing)

DrugsBladogra Myrbetriq (first dosing)Myrbetriq (second dosing)

Overview

Phase: Phase 1
Intervention: Bladogra
Conditions: Healthy
Sponsor: Genuine Research Center, Egypt
Enrollment: 29
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

January 20, 2020

End Date

May 11, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Genuine Research Center, Egypt

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female, age 18 to 55 years, inclusive.
•Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
•Medical demographics without evidence of clinically significant deviation from normal medical condition.
•Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
•Subject does not have allergy to the drugs under investigation.
•Females should be on a suitable birth control method.

Exclusion Criteria

•Subjects with known allergy to the products tested.
•Subjects whose values of BMI were outside the accepted normal ranges.
•Female subjects who were pregnant or nursing.
•Medical demographics with evidence of clinically significant deviation from normal medical condition.
•Results of laboratory tests which are clinically significant.
•Acute infection within one week preceding first study drug administration.
•History of drug or alcohol abuse.
•Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
•Subject is on a special diet (for example subject is vegetarian).
•Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.