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This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd | Experimental | Single administration : 6 days, per oral |
|
| Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd | Experimental | Single administration : 6 days, per oral |
|
| Concor 5mg 2T and Crestor 20 mg 1Tab, qd | Experimental | Combination administration : 6 days, per oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab | Drug |
| ||
| Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCÏ„(Area Under the Curve) | Administration of Investigational Product : 6 days/period(total 3 period) | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the bisoprolol and rosuvastatin:tmax,ss(Time to reach Cmax,ss), t1/2, Cmin,ss(Minimum steady-state plasma drug concentration during a dosage interval ), CL/Fss(Oral Clearance), Vd/Fss(Apparent Volume of Distribution) | Administration of Investigational Product : 6 days/period(total 3 period) | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease
Subjects with anaphylaxis to bisoprolol and/or rosuvastatin
History of drug abuse
History of caffeine, alcohol, smoking abuse
Clinical laboratory test values are outside the accepted normal range
Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
Subjects considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Jae-wook Ko, phD | Samsung Medical Conter | Principal Investigator |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Drug |
|
| Concor 5mg 2T and Crestor 20 mg 1Tab | Drug |
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |