Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

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

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.
    

Intervention name(s): Bisoprolol; Ivabradine; combination of Ivabradine and bisoprolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): bisoprolo 5 mg tablets; Ivabradine 10 mg tablet; combination of 10 mg ivabradine and 5 mg bisoprolol
Other intervention name(s): Concor; Procorloan; concor plus procorolan
Intervention MeSH terms: Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open label, randomized, single-dose, three-period, crossover design
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetic drug interaction; ivabtadine; bisoprolol