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Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

NCT ID: NCT01925300

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics Pharmacodynamics Safety Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

Single administration : 6 days, per oral

Group Type EXPERIMENTAL

Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab

Intervention Type DRUG

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

Single administration : 6 days, per oral

Group Type EXPERIMENTAL

Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

Intervention Type DRUG

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

Combination administration : 6 days, per oral

Group Type EXPERIMENTAL

Concor 5mg 2T and Crestor 20 mg 1Tab

Intervention Type DRUG

Interventions

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Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab

Intervention Type DRUG

Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

Intervention Type DRUG

Concor 5mg 2T and Crestor 20 mg 1Tab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-wook Ko, phD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Conter

Other Identifiers

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CJ_BCS_101

Identifier Type: -

Identifier Source: org_study_id