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

Cardiovascular Diseases Clinical Trial

Official title:

Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485482
• Other study ID #: PHCL36
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2018
• Last updated: March 30, 2018
• Start date: March 1, 2018
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Bisoprolol
bisoprolo 5 mg tablets
• Ivabradine
Ivabradine 10 mg tablet
• combination of Ivabradine and bisoprolol
combination of 10 mg ivabradine and 5 mg bisoprolol

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters	AUC0?8	48 hours
Primary	Pharmacokinetic parameters	AUC0?t	48 hours
Primary	Bioavailability parameters	Cmax	48 hours
Primary	Bioavailability parameters	t max	48 hours