Status:
COMPLETED
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers
Lead Sponsor:
Ain Shams University
Conditions:
Cardiovascular Diseases
Eligibility:
MALE
18-45 years
Phase:
PHASE3
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-d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03485482
Start Date
March 1 2018
End Date
March 23 2018
Last Update
April 2 2018
Active Locations (1)
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1
Faculty of Pharmacy
Cairo, Egypt