Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

Launched by HK INNO.N CORPORATION · Aug 16, 2013

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• 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