Healthy
Conditions
Keywords
Bisoprolol, Clinical equivalence, Pharmacokinetic
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.
Interventions
DRUGFirst Test Concor (Fasted)
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
DRUGFirst Reference Concor (Fasted)
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition
DRUGFirst Test Concor (Fed)
Participants will receive single oral dose of Test Concor tablet under fasted or fed condition.
DRUGFirst Reference Concor (Fed)
Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition | Pre-dose up to 48 hours post-dose on Day 1 and Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation | Baseline up to Day 30 (approximately 4 weeks) |
| Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination | Baseline up to Day 30 (approximately 4 weeks) |
Countries
China
Outcome results
None listed