Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01925300
• Other study ID #: CJ_BCS_101
• Status: Withdrawn
• Phase: Phase 1
• First received: August 15, 2013
• Last updated: December 28, 2016
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: December 2016
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

• Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

• Concor 5mg 2T and Crestor 20 mg 1Tab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCt(Area Under the Curve)	Administration of Investigational Product : 6 days/period(total 3 period)	6 days	No
Secondary	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	No