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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
46
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office
Beijing, China
Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
Time frame: Baseline up to Day 30 (approximately 4 weeks)
Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination
Time frame: Baseline up to Day 30 (approximately 4 weeks)
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Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.