Clinical trial NCT05930808: Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bisoprolol
Clinical equivalence
Pharmacokinetic
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
timeFrame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
timeFrame: Baseline up to Day 30 (approximately 4 weeks)
measure: Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination
timeFrame: Baseline up to Day 30 (approximately 4 weeks)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: