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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Test Concor (Fasted), Then Reference Concor (Fasted) | Experimental | Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by single oral dose of reference Concor tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
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| First Reference Concor (Fasted), Then Test Concor (Fasted) | Experimental | Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by single oral dose of Test Concor tablet on day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
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| First Test Concor (Fed), Then Reference Concor (Fed) | Experimental | Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Reference Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
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| First Reference Concor (Fed), Then Test Concor (Fed) | Experimental | Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Test Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First Test Concor (Fasted) | Drug | Participants will receive single oral dose of Test Concor tablet under fasted or fed condition. |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University-Drug Clinical Trial Organization Office | Beijing | China |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| First Reference Concor (Fasted) | Drug | Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition |
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| First Test Concor (Fed) | Drug | Participants will receive single oral dose of Test Concor tablet under fasted or fed condition. |
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| First Reference Concor (Fed) | Drug | Participants will receive single oral dose of Reference Concor tablet under fasted or fed condition. |
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| Baseline up to Day 30 (approximately 4 weeks) |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |