HealthyPhase 1NCT05767632

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)

A Phase 1 study testing Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose), Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test) and Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose) in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose), Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test) and Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 30 May 2022to 25 Oct 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Genuine Research Center GRC
Cairo, 11757

Other trials in Egypt

About this study

Official title: 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)

Read the 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
Being tested: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose), Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test), Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)Drug
Also called Vesicare & Betmiga
1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water
Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)Drug
Also called Mirfenacin MR
1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water
Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)Drug
Also called Vesicare & Betmiga
1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

Study groups in NCT05767632
Study group	Role	What they receive
R reference (first dose)	Active comparator	Reference drugs (Vesicare \& Betmiga) Receives: Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)
T test	Experimental	Test drug (Mirfenacin MR) Receives: Drug: Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)
R reference (second dose)	Active comparator	Reference drugs (Vesicare \& Betmiga) Receives: Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

For Solifenacin: Cmax
to measure the maximal measured plasma concentration
Measured: 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
Measured: Up to 72 hours post dose in each treatment period
For Mirabegron: Cmax
to measure the maximal measured plasma concentration
Measured: 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
Measured: 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
Measured: Up to 240 hours post dose in each treatment period

Secondary outcomes (1)

For Solifenacin & Mirabegron: Tmax
Time of the maximum plasma concentration
Measured: For Solifenacin:Up to 72 hours post dose in each treatment period & For Mirabegron:Up to 240 hours post dose in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202225 Oct 2022

First posted14 Mar 2023
Study start30 May 2022
Primary completion25 Jul 2022
Study completion25 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: An open label randomized, single dose, three-way, partial replicate crossover design
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05767632
Sponsor's protocol ID: GRC/1/21/998
Status last verified: Mar 2023
First submitted: 21 Feb 2023
Last updated: 14 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 11381568
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.
PubMed 3450848
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.
PubMed 2004861

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05767632
Acronym / sponsor ID: GRC/1/21/998
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
Collaborators: Hikma Pharma
Study start: 30 May 2022 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 25 Oct 2022 (actual)
First posted: 14 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

For Solifenacin:

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

For Mirabegron:

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: An open label randomized, single dose, three-way, partial replicate crossover design

Arm	Type	Receives
R reference (first dose)	Active comparator	Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)Reference drugs (Vesicare \& Betmiga)
T test	Experimental	Drug: Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)Test drug (Mirfenacin MR)
R reference (second dose)	Active comparator	Drug: Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)Reference drugs (Vesicare \& Betmiga)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)Also: Vesicare & Betmiga1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water	Drug	R reference (first dose)
Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)Also: Mirfenacin MR1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water	Drug	T test
Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)Also: Vesicare & Betmiga1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water	Drug	R reference (second dose)

Primary outcome

For Solifenacin: Cmax
Time frame: Up to 72 hours post dose in each treatment period
to measure the maximal measured plasma concentration
For Solifenacin: truncated AUC0→72
Time frame: Up to 72 hours post dose in each treatment period
to measure truncated area under the curve from zero time to 72 hours
For Mirabegron: Cmax
Time frame: Up to 240 hours post dose in each treatment period
to measure the maximal measured plasma concentration
For Mirabegron: AUC0→t
Time frame: Up to 240 hours post dose in each treatment period
to measure the area under the curve from zero time to 240 hours
For Mirabegron: AUC0→∞
Time frame: Up to 240 hours post dose in each treatment period
to measure the area under the curve from zero time to infinity

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Background: PubMed 11381568Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
Background: PubMed 3450848Schuirmann 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.
Background: PubMed 2004861Diletti 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmed Elshafeey, Ph.D. Pharma study director

Genuine Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For Solifenacin: Cmax (time frame: Up to 72 hours post dose in each treatment period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767632, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.