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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)

NCT04476966 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-07-21

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Bladogra

1 tablet contains 25 mg Mirabegron

DRUG

Myrbetriq (first dosing)

1 tablet contains 25 mg Mirabegron

DRUG

Myrbetriq (second dosing)

1 tablet contains 25 mg Mirabegron

Sponsors & Collaborators

  • Multi-Apex Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2020-03-02
Completion
2020-05-11

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476966 on ClinicalTrials.gov