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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930808
• Other study ID #: MS200006_0131
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2023
• Est. completion date: June 18, 2023

Study information

• Verified date: July 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• First Test Concor (Fasted)
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
• First Reference Concor (Fasted)
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
• First Test Concor (Fed)
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
• First Reference Concor (Fed)
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination		Baseline up to Day 30 (approximately 4 weeks)

External Links

•   Trial Awareness and Transparency website