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

NCT05930808 | Completed Phase 1

• 1 other identifier: MS200006_0131
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Bisoprolol; Clinical equivalence; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (4)

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.

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.

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.

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.

Drug: First Reference Concor (Fed)

Interventions

First Test Concor (Fasted) DRUG

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

Also known as: Bisoprolol

First Test Concor (Fasted), Then Reference Concor (Fasted)

First Reference Concor (Fasted) DRUG

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

Also known as: Bisoprolol

First Reference Concor (Fasted), Then Test Concor (Fasted)

First Test Concor (Fed) DRUG

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

Also known as: Bisoprolol

First Test Concor (Fed), Then Reference Concor (Fed)

First Reference Concor (Fed) DRUG

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

Also known as: Bisoprolol

First Reference Concor (Fed), Then Test Concor (Fed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

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

Beijing, China

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Bisoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: February 28, 2023
• Primary Completion: June 18, 2023
• Study Completion: June 18, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)