Pharmacokinetics, hypertension, amlodipine besilate, oral liquid. Farmacokinetiek, hypertensie, amlodipine besilaat, orale drank.
Conditions
Interventions
All participants will be randomly assigned to receive a single dose of Norvasc tablets 5 mg or 5 mg of amlodipine besilate oral liquid 0,5 mg/ml and after a two-week washout period the other formulati
Sponsors
Erasmus Medical Centre
es Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
Phone: +31(0) 10-7040704
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is healthy; 2. Subject is Caucasian; 3. Age is between 18-55 years; 4. Body Mass Index (BMI) is between 19-25; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Sitting blood pressure lower than 120 mmHg systolic and/or 80 mmHg diastolic in resting conditions; 2. Use of medication, both medicines on prescription and over-the-counter medicines, excluding contraceptives; 3. 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; 4. Allergy for one of the substances of both formulations; 5. Pregnancy; 6. Smoking; 7. Subject has history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters Cmax, tmax, AUC0-72, AUC‡ of amlodipine besilate oral liquid 0,5 mg/ml and Norvasc tablets 5 mg will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to be determined using a questionnaire. | — |
Contacts
Public ContactL. Hanff
Outcome results
None listed