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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Healthy

Intervention / Treatment
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* Drug: First Test Concor (Fasted)
* Drug: First Reference Concor (Fasted)
* Drug: First Test Concor (Fed)
* Drug: First Reference Concor (Fed)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Test Concor (Fasted), Then Reference Concor (Fasted)<br>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. | Drug: First Test Concor (Fasted)<br>* Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.<br>* Other names: Bisoprolol;|
| Experimental: First Reference Concor (Fasted), Then Test Concor (Fasted)<br>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. | Drug: First Reference Concor (Fasted)<br>* Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition<br>* Other names: Bisoprolol;|
| Experimental: First Test Concor (Fed), Then Reference Concor (Fed)<br>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. | Drug: First Test Concor (Fed)<br>* Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.<br>* Other names: Bisoprolol;|
| Experimental: First Reference Concor (Fed), Then Test Concor (Fed)<br>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. | Drug: First Reference Concor (Fed)<br>* Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.<br>* Other names: Bisoprolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition |  | Pre-dose up to 48 hours post-dose on Day 1 and Day 8 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bisoprolol, Clinical equivalence, Pharmacokinetic