Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office
Beijing, China
NCT Number: NCT05930808
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
Other names: Bisoprolol
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
Other names: Bisoprolol
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
Other names: Bisoprolol
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.
Other names: Bisoprolol
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Time frame: Baseline up to Day 30 (approximately 4 weeks)
Time frame: Baseline up to Day 30 (approximately 4 weeks)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
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
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