Status:
COMPLETED
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)
Lead Sponsor:
Genuine Research Center, Egypt
Collaborating Sponsors:
Multi-Apex Pharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
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 interval...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drug administration.
- Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04476966
Start Date
January 20 2020
End Date
May 11 2020
Last Update
July 21 2020
Active Locations (1)
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1
Genuine Research Center GRC
Cairo, Egypt, 11511