Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)

NCT05767632 | Completed Phase 1

• 1 other identifier: GRC/1/21/998
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An open label randomized, single dose, three-way, partial replicate bioequivalence study to determine the bioequivalence of Solifenacin Succinate \& Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg Film Coated Tablets \& Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• For Solifenacin: Cmax

  to measure the maximal measured plasma concentration

  Up to 72 hours post dose in each treatment period

• For Solifenacin: truncated AUC0→72

  to measure truncated area under the curve from zero time to 72 hours

  Up to 72 hours post dose in each treatment period

• For Mirabegron: Cmax

  to measure the maximal measured plasma concentration

  Up to 240 hours post dose in each treatment period

• For Mirabegron: AUC0→t

  to measure the area under the curve from zero time to 240 hours

  Up to 240 hours post dose in each treatment period

• For Mirabegron: AUC0→∞

  to measure the area under the curve from zero time to infinity

  Up to 240 hours post dose in each treatment period

Secondary Outcomes (1)

• For Solifenacin & Mirabegron: Tmax

  For Solifenacin:Up to 72 hours post dose in each treatment period & For Mirabegron:Up to 240 hours post dose in each treatment period

Study Arms (3)

R reference (first dose)

ACTIVE COMPARATOR

Reference drugs (Vesicare \& Betmiga)

Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)

T test

EXPERIMENTAL

Test drug (Mirfenacin MR)

Drug: Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)

R reference (second dose)

ACTIVE COMPARATOR

Reference drugs (Vesicare \& Betmiga)

Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)

Interventions

Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose) DRUG

1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

Also known as: Vesicare & Betmiga

R reference (first dose)

Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test) DRUG

1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water

Also known as: Mirfenacin MR

T test

Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose) DRUG

1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

Also known as: Vesicare & Betmiga

R reference (second dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Females should be on a suitable birth control method.
• Fully informed subjects that consented to participate in the study.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects who meet any of the contraindications to the administration of Solifenacin succinate and/or Mirabegron.
• Subject does not agree not to consume any medication or food which may affect CYP3A4 enzyme at least two weeks prior to first study drug administration until donating the last sample of the study.
• Subjects that do not agree not to consume alcohol-containing beverages and foods for 2 weeks before dosing and throughout the period of sample collection.
• Heavy smokers.
• Female subjects who were pregnant or nursing.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not comply with the stated instruction of not taking 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 14 days prior to first study drug administration until the end of the study.
• Subject has a family history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Hikma Pharma: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• 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.

  PMID: 11381568 BACKGROUND

• 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.

  PMID: 3450848 BACKGROUND

• 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.

  PMID: 2004861 BACKGROUND

MeSH Terms

Interventions

Solifenacin Succinate; mirabegron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label randomized, single dose, three-way, partial replicate crossover design

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 14, 2023
• Study Start: May 30, 2022
• Primary Completion: July 25, 2022
• Study Completion: October 25, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)