HealthyPhase 1NCT05930808

Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong)

A Phase 1 study testing First Test Concor (Fasted), First Reference Concor (Fasted) and First Test Concor (Fed) in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in China.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess is the bioequivalence (BE) of Concor 5 milligram (mg) tablets manufactured by Merck/China Nantong (test product) and Concor 5 mg tablets manufactured by Merck/Germany Darmstadt (reference product) in Chinese healthy participants under fed or fasted condition. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: First Test Concor (Fasted), First Reference Concor (Fasted) and First Test Concor (Fed)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteChina
Study dates: 28 Feb 2023to 18 Jun 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring
Participant must have a body weight within 50-90 kilogram (kg) and body mass index (BMI) within the range 19-26 kilogram per meter square (kg/m2) (inclusive)
Participant must have negative screen for alcohol and drugs of abuse at screening and on admission
Both male and female participants. The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF
Other protocol defined inclusion criteria could apply

Who cannot join

Participant must not have any condition, including any uncontrolled disease state, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Participant should not have positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, and treponema pallidum antibodies
Participant must not have received any prescription or non-prescription medication within 28 days before the first study intervention administration, including multivitamins and herbal products (example, St John's Wort, or traditional Chinese medicines)
Participant must not have participation in a study trial within 90 days prior to first drug administration; Blood donation (equal or more than 400 milliliter [mL]) or significant blood loss within 90 days prior to first drug administration
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office
Beijing

Other trials in China

About this study

Official title: A Randomized, Open-label, 2-way-crossover Study Assessing the Bioequivalence Between Single Doses of 5 mg Concor® Tablets (Manufactured by Merck/China Nantong) and 5 mg Concor® Tablets (Manufactured by Merck/Germany Darmstadt) in Chinese Healthy Participants Under Fed or Fasted Conditions

Conditions: Healthy
Being tested: First Test Concor (Fasted), First Reference Concor (Fasted), First Test Concor (Fed), First Reference Concor (Fed)
Keywords: Bisoprolol, Clinical equivalence, Pharmacokinetic

What participants receive

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

First Test Concor (Fasted)Drug
Also called Bisoprolol
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
First Reference Concor (Fasted)Drug
Also called Bisoprolol
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
First Test Concor (Fed)Drug
Also called Bisoprolol
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
First Reference Concor (Fed)Drug
Also called Bisoprolol
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Study groups in NCT05930808
Study group	Role	What they receive
First Test Concor (Fasted), Then Reference Concor (Fasted)	Experimental	Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by single oral dose of reference Concor tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: First Test Concor (Fasted)
First Reference Concor (Fasted), Then Test Concor (Fasted)	Experimental	Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by single oral dose of Test Concor tablet on day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: First Reference Concor (Fasted)
First Test Concor (Fed), Then Reference Concor (Fed)	Experimental	Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Reference Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: First Test Concor (Fed)
First Reference Concor (Fed), Then Test Concor (Fed)	Experimental	Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Test Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: First Reference Concor (Fed)

What is being measured

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

Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
Measured: Pre-dose up to 48 hours post-dose on Day 1 and Day 8

Secondary outcomes (2)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
Measured: Baseline up to Day 30 (approximately 4 weeks)
Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination
Measured: Baseline up to Day 30 (approximately 4 weeks)

Timeline

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

28 Feb 202318 Jun 2023

First posted5 Jul 2023
Study start28 Feb 2023
Primary completion18 Jun 2023
Study completion18 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05930808
Sponsor's protocol ID: MS200006_0131
Status last verified: Jul 2023
First submitted: 26 Jun 2023
Last updated: 2 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, 2-way-crossover Study Assessing the Bioequivalence Between Single Doses of 5 mg Concor® Tablets (Manufactured by Merck/China Nantong) and 5 mg Concor® Tablets (Manufactured by Merck/Germany Darmstadt) in Chinese Healthy Participants Under Fed or Fasted Conditions
ClinicalTrials.gov ID: NCT05930808
Acronym / sponsor ID: MS200006_0131
Conditions: Healthy
Keywords: Bisoprolol, Clinical equivalence, Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 28 Feb 2023 (actual)
Primary completion: 18 Jun 2023 (actual)
Study completion: 18 Jun 2023 (actual)
First posted: 5 Jul 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
First Test Concor (Fasted), Then Reference Concor (Fasted)	Experimental	Drug: First Test Concor (Fasted)Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by single oral dose of reference Concor tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Reference Concor (Fasted), Then Test Concor (Fasted)	Experimental	Drug: First Reference Concor (Fasted)Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by single oral dose of Test Concor tablet on day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test Concor (Fed), Then Reference Concor (Fed)	Experimental	Drug: First Test Concor (Fed)Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Reference Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Reference Concor (Fed), Then Test Concor (Fed)	Experimental	Drug: First Reference Concor (Fed)Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Test Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring
Participant must have a body weight within 50-90 kilogram (kg) and body mass index (BMI) within the range 19-26 kilogram per meter square (kg/m2) (inclusive)
Participant must have negative screen for alcohol and drugs of abuse at screening and on admission
Both male and female participants. The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF

Key exclusion criteria (5 listed)

Participant must not have any condition, including any uncontrolled disease state, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Participant should not have positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, and treponema pallidum antibodies
Participant must not have received any prescription or non-prescription medication within 28 days before the first study intervention administration, including multivitamins and herbal products (example, St John's Wort, or traditional Chinese medicines)
Participant must not have participation in a study trial within 90 days prior to first drug administration; Blood donation (equal or more than 400 milliliter [mL]) or significant blood loss within 90 days prior to first drug administration
Other protocol defined exclusion criteria could apply

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
First Test Concor (Fasted)Also: BisoprololParticipants will receive single oral dose of Test Concor tablet under fasted or fed condition.	Drug	First Test Concor (Fasted), Then Reference Concor (Fasted)
First Reference Concor (Fasted)Also: BisoprololParticipants will receive single oral dose of Reference Concor tablet under fasted or fed condition	Drug	First Reference Concor (Fasted), Then Test Concor (Fasted)
First Test Concor (Fed)Also: BisoprololParticipants will receive single oral dose of Test Concor tablet under fasted or fed condition.	Drug	First Test Concor (Fed), Then Reference Concor (Fed)
First Reference Concor (Fed)Also: BisoprololParticipants will receive single oral dose of Reference Concor tablet under fasted or fed condition.	Drug	First Reference Concor (Fed), Then Test Concor (Fed)

Primary outcome

Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8

2 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
Time frame: Baseline up to Day 30 (approximately 4 weeks)
Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination
Time frame: Baseline up to Day 30 (approximately 4 weeks)

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 2 Aug 2023.
Trial Awareness and Transparency websiteLink provided by the sponsor.
Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

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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.

Medical Responsible study director

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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 5 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 2 Aug 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 China. 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?

Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition (time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8). 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 NCT05930808.

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 2 Aug 2023.