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…
ID
Bron
Verkorte titel
Aandoening
Pharmacokinetics, hypertension, amlodipine besilate, oral liquid. Farmacokinetiek, hypertensie, amlodipine besilaat, orale drank.
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Wetenschappers
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3520 |
| NTR-old | NTR3682 |
| Ander register | EudraCT : 2012-004065-41 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |