Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

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

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

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