Skip to main content
OpenTrials
Completed

NCT Number: NCT05930808

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First Test Concor (Fasted)

Drug

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

Other names: Bisoprolol

First Reference Concor (Fasted)

Drug

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition

Other names: Bisoprolol

First Test Concor (Fed)

Drug

Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.

Other names: Bisoprolol

First Reference Concor (Fed)

Drug

Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.

Other names: Bisoprolol

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.