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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01925300

Enrollment

Registered

2013-08-19

Start date

2013-07-31

Completion date

2013-09-30

Last updated

2016-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability

Brief summary

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

Interventions

DRUGConcor 5mg(Bisoprolol hemifumarate 5mg) 2Tab

DRUGCrestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

DRUGConcor 5mg 2T and Crestor 20 mg 1Tab

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026