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

NCT03485482 | Completed Phase 3 DMC

• 1 other identifier: PHCL36
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Keywords

Pharmacokinetic drug interaction; ivabtadine; bisoprolol

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameters

  AUC0→∞

  48 hours

• Pharmacokinetic parameters

  AUC0→t

  48 hours

• Bioavailability parameters

  Cmax

  48 hours

• Bioavailability parameters

  t max

  48 hours

Study Arms (3)

Group Ivabradine

EXPERIMENTAL

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

Drug: Ivabradine

Group Bisoprolol

EXPERIMENTAL

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

Drug: Bisoprolol

Group combination

EXPERIMENTAL

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

Interventions

Bisoprolol DRUG

bisoprolo 5 mg tablets

Also known as: Concor

Group Bisoprolol

Ivabradine DRUG

Ivabradine 10 mg tablet

Also known as: Procorloan

Group Ivabradine

combination of Ivabradine and bisoprolol DRUG

combination of 10 mg ivabradine and 5 mg bisoprolol

Also known as: concor plus procorolan

Group combination

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
• Subjects who have taken any medication less than two weeks of the trials starting date.
• Susceptibility to allergic reactions to study drugs.
• Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
• Gastrointestinal diseases.
• Renal diseases.
• Cardiovascular diseases.
• Pancreatic disease including diabetes.
• Hepatic diseases.
• Hematological disease or pulmonary disease
• Abnormal laboratory values.
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Pharmacy

Cairo, Egypt

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Bisoprolol; Ivabradine

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sara Shaheen, Ass. Prof

  Faculty of pharamacy, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of pharmacy, Ain Shams University

Model Details: open label, randomized, single-dose, three-period, crossover design

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 2, 2018
• Study Start: March 1, 2018
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)