Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

HK inno.N

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab; Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab; Drug: Concor 5mg 2T and Crestor 20 mg 1Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01925300

CJ_BCS_101

Details and patient eligibility

About

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

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd

Experimental group

Description:

Single administration : 6 days, per oral

Treatment:

Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab

Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd

Experimental group

Description:

Single administration : 6 days, per oral

Treatment:

Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

Concor 5mg 2T and Crestor 20 mg 1Tab, qd

Experimental group

Description:

Combination administration : 6 days, per oral

Treatment:

Drug: Concor 5mg 2T and Crestor 20 mg 1Tab