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

NCT ID: NCT05930808

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2023-06-18

Brief 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.

Conditions

Healthy

Study Design

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

Study Groups

First Test Concor (Fasted), Then Reference 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.

Group Type: EXPERIMENTAL

First Test Concor (Fasted)

Intervention Type: DRUG

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

First Reference Concor (Fasted), Then Test 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.

Group Type: EXPERIMENTAL

First Reference Concor (Fasted)

Intervention Type: DRUG

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition

First Test Concor (Fed), Then Reference 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.

Group Type: EXPERIMENTAL

First Test Concor (Fed)

Intervention Type: DRUG

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

First Reference Concor (Fed), Then Test 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.

Group Type: EXPERIMENTAL

First Reference Concor (Fed)

Intervention Type: DRUG

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Interventions

First Test Concor (Fasted)

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

Intervention Type: DRUG

First Reference Concor (Fasted)

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition

Intervention Type: DRUG

First Test Concor (Fed)

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

Intervention Type: DRUG

First Reference Concor (Fed)

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Intervention Type: DRUG

Other Intervention Names

Bisoprolol; Bisoprolol; Bisoprolol; Bisoprolol

Eligibility Criteria

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

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

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

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

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

Locations

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

Beijing, , China

Countries

China

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200006_0131

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

MS200006_0131

Identifier Type: -

Identifier Source: org_study_id