Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin

NCT01925300 | Withdrawn Phase 1

• 1 other identifier: CJ_BCS_101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics; Pharmacodynamics; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• 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)

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

  6 days

Secondary Outcomes (1)

• 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

Study Arms (3)

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

EXPERIMENTAL

Single administration : 6 days, per oral

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

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

EXPERIMENTAL

Single administration : 6 days, per oral

Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab

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

EXPERIMENTAL

Combination administration : 6 days, per oral

Drug: Concor 5mg 2T and Crestor 20 mg 1Tab

Interventions

Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab DRUG

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

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

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

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

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

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Interventions

Bisoprolol; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jae-wook Ko, phD

  Samsung Medical Conter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 29, 2016

Record last verified: 2016-12