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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: First Test Concor (Fed); Drug: First Reference Concor (Fed); Drug: First Test Concor (Fasted); Drug: First Reference Concor (Fasted)

• Registration Number: NCT05930808
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Primary Completion: 2023-06-18
• Study Completion: 2023-06-18
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Status Verified: 2023-07
• Study First Posted: 2023-07-05
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Test Concor (Fed), Then Reference Concor (Fed)	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)	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.
First Test Concor (Fasted), Then Reference Concor (Fasted)	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)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination	Baseline up to Day 30 (approximately 4 weeks)
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)

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office; 🇨🇳 Beijing, China