Trials / Completed
CompletedNCT04476966
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-01-20
- Primary completion
- 2020-03-02
- Completion
- 2020-05-11
- First posted
- 2020-07-20
- Last updated
- 2020-07-21
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04476966. Inclusion in this directory is not an endorsement.