Comparative study of pharmacokinetics of amlodipine besilate oral liquid and tablets in healthy Dutch volunteers

Phase 4

Completed

• Conditions: high blood pressure; Hypertension; 10057166

• Registration Number: NL-OMON36940
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

•Subject is healthy
•Subject is Caucasian
•Age is between 18-55 years
•Body Mass Index (BMI) is between 19-25
•Written informed consent

Exclusion Criteria

•Sitting blood pressure lower than 120 mmHg systolic and/or 80 mmHg diastolic in resting conditions
•Use of medication, both medicines on prescription and over-the-counter medicines, excluding contraceptives
•Subject is familiar with one of the contra-indications of amlodipine: hypersensitivity to dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction
•Allergy for one of the substances of both formulations
•Pregnancy
•Smoking
•Subject has history of alcohol or drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetic parameters Cmax, tmax, AUC0-72, AUC* of amlodipine besilate<br /><br>oral liquid 0,5 mg/ml and Norvasc tablets 5 mg will be assessed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to<br /><br>be determined using a questionnaire. </p><br>