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

NCT ID: NCT03485482

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-03-23

Brief 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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group Ivabradine

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

Group Type: EXPERIMENTAL

Ivabradine

Intervention Type: DRUG

Ivabradine 10 mg tablet

Group Bisoprolol

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

Group Type: EXPERIMENTAL

Bisoprolol

Intervention Type: DRUG

bisoprolo 5 mg tablets

Group combination

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

Group Type: EXPERIMENTAL

combination of Ivabradine and bisoprolol

Intervention Type: DRUG

combination of 10 mg ivabradine and 5 mg bisoprolol

Interventions

Bisoprolol

bisoprolo 5 mg tablets

Intervention Type: DRUG

Ivabradine

Ivabradine 10 mg tablet

Intervention Type: DRUG

combination of Ivabradine and bisoprolol

combination of 10 mg ivabradine and 5 mg bisoprolol

Intervention Type: DRUG

Other Intervention Names

Concor; Procorloan; concor plus procorolan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mahmoud Shaheen

Associate Professor, Faculty of pharmacy, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Shaheen, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

Faculty of pharamacy, Ain Shams University

Locations

Faculty of Pharmacy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PHCL36

Identifier Type: -

Identifier Source: org_study_id