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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: First Reference Concor (Fasted); Drug: First Reference Concor (Fed); Drug: First Test Concor (Fed); Drug: First Test Concor (Fasted)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05930808

MS200006_0131

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: First Test Concor (Fasted)

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

Experimental group

Description:

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.

Treatment:

Drug: First Reference Concor (Fasted)

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

Experimental group

Description:

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.

Treatment:

Drug: First Test Concor (Fed)

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

Experimental group

Description:

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.

Treatment:

Drug: First Reference Concor (Fed)