Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

Study Overview
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Brief Summary
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This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.

Official Title
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A Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab
* Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab
* Drug: Concor 5mg 2T and Crestor 20 mg 1Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 55 years old(inclusive) Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive) Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute) Available for the entire study period Understand the requirements of the study and voluntarily consent to participate in the study 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 caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day smoking > 20 cigarettes/day alcohol > 140g/week Clinical laboratory test values are outside the accepted normal range AST(Aspartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range CK(Creatine Kinase) > 1.5 times to normal range Estimated GFR(Glomerular Filtration Rate) < 60 mL/min 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd<br>Single administration : 6 days, per oral | Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab<br> <br> |
| Experimental: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd<br>Single administration : 6 days, per oral | Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab<br> <br> |
| Experimental: Concor 5mg 2T and Crestor 20 mg 1Tab, qd<br>Combination administration : 6 days, per oral | Drug: Concor 5mg 2T and Crestor 20 mg 1Tab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 ), AUCτ(Area Under the Curve) | Administration of Investigational Product : 6 days/period(total 3 period) | 6 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamics, Pharmacokinetics, Safety, Tolerability