NCT05930808

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	First Test Concor (Fasted)	Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
DRUG	First Reference Concor (Fasted)	Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
DRUG	First Test Concor (Fed)	Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
DRUG	First Reference Concor (Fed)	Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-06-18
• Completion: 2023-06-18
• First posted: 2023-07-05
• Last updated: 2023-08-02

Locations

1 site across 1 country: China