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

NCT05930808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-08-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-06-18
Completion
2023-06-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930808 on ClinicalTrials.gov