Comparison of the pharmacokinetics of amlodipine besilate oral liquid and tablets

• Conditions: Hypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-004065-41-NL
• Lead Sponsor: Erasmus Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (16-17)
•Allergy for one of the substances of both formulations
•Pregnancy
•Smoking
•Subject has history of alcohol or drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified