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

Last updated: March 30, 2018
Sponsor: Ain Shams University
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT03485482
PHCL36
  • Ages 18-45
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects should be healthy adult volunteers with age between (18-45 years) with normal bodyweight. Subjects should understand the procedures and are willing to participate and gavetheir final written consent prior to the commencement of the study procedures. Thevolunteers will be asked to provide a complete medical history, and complete a physicalexamination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihumanimmunodeficiency virus antibody).

Exclusion

Exclusion Criteria:

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

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

  3. Susceptibility to allergic reactions to study drugs.

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

  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 studyrequiring a large volume of blood (more than 500 ml) to be drawn within 6 weekspreceding the start of the study.

Study Design

Total Participants: 18
Study Start date:
March 01, 2018
Estimated Completion Date:
March 23, 2018

Study 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.

Connect with a study center

  • Faculty of Pharmacy

    Cairo,
    Egypt

    Site Not Available

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