Clinical trial NCT04476966: 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)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Genuine Research Center, Egypt
Sponsor class: INDUSTRY
Collaborators: name: Multi-Apex Pharma
First posted: 2020-07-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: three way three sequence two treatment partial replicate crossover bioequivalence study
Primary purpose: OTHER

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.

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.
* 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.

Primary outcomes:
measure: Cmax
timeFrame: Up to 72 hours post dose in each treatment period
Secondary outcomes:
measure: Time of the maximum plasma concentration (Tmax)
timeFrame: Up to 72 hours post dose in each treatment period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Genuine Research Center GRC
Study officials:
affiliation: Genuine Research Center
name: Ahmed Elshafeey, Ph.D. Pharma
role: STUDY_DIRECTOR
References:
citation: Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
citation: Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
citation: Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.