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)

NCT ID: NCT05767632

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-10-25

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)

Detailed Description

Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 30 Healthy volunteers (28 volunteers + 2 extra volunteers to compensate for drop-outs) will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report.

For Solifenacin:

Primary Pharmacokinetic Parameters: Cmax and truncated AUC0→72 Secondary Pharmacokinetic Parameters: Tmax

For Mirabegron:

Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for log transformed (with the 90% confidence intervals), untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e, for Mirabegron and untransformed data of Cmax and truncated AUC0→t and for untransformed data of tmax for Solifenacin.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

R reference (first dose)

Reference drugs (Vesicare \& Betmiga)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

T test

Test drug (Mirfenacin MR)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

R reference (second dose)

Reference drugs (Vesicare \& Betmiga)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Vesicare & Betmiga; Mirfenacin MR; Vesicare & Betmiga

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female, age 18 to 55 years, inclusive.

2. Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI).

3. 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.

4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.

5. Females should be on a suitable birth control method.

6. Fully informed subjects that consented to participate in the study.

Exclusion Criteria

1. Subjects with known allergy to the products tested.

2. Subjects who meet any of the contraindications to the administration of Solifenacin succinate and/or Mirabegron.

3. 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.

4. 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.

5. Heavy smokers.

6. Female subjects who were pregnant or nursing.

7. Acute infection within one week preceding first study drug administration.

8. History of drug or alcohol abuse.

9. 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.

10. Subject is on a special diet (for example subject is vegetarian).

11. 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.

12. 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.

13. Subject has a family history of severe diseases which have direct impact on the study.

14. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.

15. Subject intends to be hospitalized within 3 months after first study drug administration.

16. Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hikma Pharma

UNKNOWN

Sponsor Role: collaborator

Genuine Research Center, Egypt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Elshafeey, Ph.D. Pharma

Role: STUDY_DIRECTOR

Genuine Research Center

Locations

Genuine Research Center GRC

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 11381568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3450848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2004861 (View on PubMed)

Other Identifiers

GRC/1/21/998

Identifier Type: -

Identifier Source: org_study_id