No registrations found.
ID
Source
Brief title
Health condition
Pharmacokinetics, hypertension, amlodipine besilate, oral liquid. Farmacokinetiek, hypertensie, amlodipine besilaat, orale drank.
Sponsors and support
es Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
Phone: +31(0) 10-7040704
Laan van Nieuw Oost-Indie 334, 2593 CE The Hague, The Netherlands
Phone: +31(0) 70-3495111, Fax: +31(0) 70-3495100,
E-mail: info@zonmw.nl
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to be determined using a questionnaire.
Background summary
N/A
Study objective
Amlodipine is prescribed off-label for paediatric patients, but there is no safe, efficacious and appropriate paediatric formulation available. Therefore, an appropriate amlodipine besilate oral liquid 0,5 mg/ml is developed. In order to establish safety and efficacy of this formulation, the pharmacokinetics of the new oral liquid is compared with commercial available tablets in healthy volunteers.
Study design
All pharmacokinetic parameters will be evaluated after completion of the
study. The taste of amlodipine besilate oral liquid 0,5 mg/ml will be evaluated
by the subjects directly after intake using a questionnaire. The
questionnaires will be evaluated by the investigators after completion of the study.
Intervention
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 formulation will be administered.
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3520 |
| NTR-old | NTR3682 |
| Other | EudraCT : 2012-004065-41 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |