Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

Phase 1

Withdrawn

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

• Registration Number: NCT01925300
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-19
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd	Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab	Single administration : 6 days, per oral
Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd	Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab	Single administration : 6 days, per oral
Concor 5mg 2T and Crestor 20 mg 1Tab, qd	Concor 5mg 2T and Crestor 20 mg 1Tab	Combination administration : 6 days, per oral

Primary Outcome Measures

Name	Time	Method
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)	6 days	Administration of Investigational Product : 6 days/period(total 3 period)

Secondary Outcome Measures

Name	Time	Method
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)	6 days	Administration of Investigational Product : 6 days/period(total 3 period)