Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03485482
Collaborator
(none)
18
1
3
22
24.9

Study Details

Study Description

Brief Summary

The purpose of the study was to investigate the potential interaction between ivabradine and bisoprolol in healthy subjects.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The aim of this study is to undergo a pharmacokinetic study to investigate the incidence of potential pharmacokinetic interaction between Ivabradine and Bisoprolol through the Assessment of the drug-drug interactions of Ivabradine and Bisoprolol by determination of pharmacokinetic parameters of both drugs administered alone and in combination. The pharmacokinetic parameters will include; The maximum plasma concentration (Cmax),the time to reach the peak concentration (tmax), area under the concentration-time curve (AUC0-t) and (AUC0-∞) during the treatment periods, the absorption and elimination rate constants (ka and kel), the half-life and mean residence time (MRT).

Study design A comparative randomized open-label three-period crossover study of ivabradine/ bisoprolol in male healthy human volunteers

Methodology

Eighteen healthy volunteer will be recruited in the study and will be divided into three groups each consisting of six volunteers as follows:

Period I:
  • Group A: Six Volunteers will receive single 10 mg oral dose of ivabradin (Procoralan®, Les Laboratoires Servier Industrie-France).

  • Group B: Six Volunteers will receive single oral dose of bisoprolol 5mg (Concor®).

  • Group C: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg

Period II:
  • Group A: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg

  • Group B: Six Volunteers will receive single 10 mg oral dose of ivabradin.

  • Group C: Six Volunteers will receive single oral dose of bisoprolol 5mg.

Period III:
  • Group A: Six Volunteers will receive single oral dose of bisoprolol 5mg.

  • Group B: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg

  • Group C: Six Volunteers will receive single 10 mg oral dose of ivabradin

All drug administration will be followed by 240 ml of water after at least 10 h fasting prior to administration. The three treatment periods will be separated by a one week washout period. Standardized meals will be served at 2, 5, and 10 h after drug dosing. All subjects should abstain from the consumption of fruit juices during the study period.

Subject Selection Criteria Eighteen adult male volunteers will be enrolled. Subjects should understand the procedures and are willing to participate and give their final written consent prior to the commencement of the study procedures.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
open label, randomized, single-dose, three-period, crossover designopen label, randomized, single-dose, three-period, crossover design
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover Clinical Study
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Mar 23, 2018
Actual Study Completion Date :
Mar 23, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Ivabradine

six healthy volunteers will administer Ivabradin tablet only once single 10 mg oral dose

Drug: Ivabradine
Ivabradine 10 mg tablet
Other Names:
  • Procorloan
  • Experimental: Group Bisoprolol

    six healthy volunteers will administer bisoprolol tablet only once single oral dose of 5mg

    Drug: Bisoprolol
    bisoprolo 5 mg tablets
    Other Names:
  • Concor
  • Experimental: Group combination

    six healthy volunteers will administer only once a combination of a single dose of ivabradine 10 mg and bisoprolol 5 mg

    Drug: combination of Ivabradine and bisoprolol
    combination of 10 mg ivabradine and 5 mg bisoprolol
    Other Names:
  • concor plus procorolan
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic parameters [48 hours]

      AUC0→∞

    2. Pharmacokinetic parameters [48 hours]

      AUC0→t

    3. Bioavailability parameters [48 hours]

      Cmax

    4. Bioavailability parameters [48 hours]

      t max

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Subjects should be healthy adult volunteers with age between (18-45 years) with normal body weight. Subjects should understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures. The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).

    Exclusion Criteria:
    1. Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.

    2. Subjects who have taken any medication less than two weeks of the trials starting date.

    3. Susceptibility to allergic reactions to study drugs.

    4. Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

    5. Gastrointestinal diseases.

    6. Renal diseases.

    7. Cardiovascular diseases.

    8. Pancreatic disease including diabetes.

    9. Hepatic diseases.

    10. Hematological disease or pulmonary disease

    11. Abnormal laboratory values.

    12. Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Pharmacy Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Sara Shaheen, Ass. Prof, Faculty of pharamacy, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Mahmoud Shaheen, Associate Professor, Faculty of pharmacy, Ain Shams University, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03485482
    Other Study ID Numbers:
    • PHCL36
    First Posted:
    Apr 2, 2018
    Last Update Posted:
    Apr 2, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Mahmoud Shaheen, Associate Professor, Faculty of pharmacy, Ain Shams University, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 2, 2018