Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

December 28, 2016 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 6 days
Administration of Investigational Product : 6 days/period(total 3 period)
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 6 days
Administration of Investigational Product : 6 days/period(total 3 period)
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Jae-wook Ko, phD, Samsung Medical Conter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJ_BCS_101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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