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


- candidate number13494
- NTR NumberNTR3682
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2012
- Secondary IDs2012-004065-41  EudraCT
- Public TitleComparative study of pharmacokinetics of amlodipine besilate oral liquid and tablets in healthy Dutch volunteers.
- Scientific TitleComparative study of pharmacokinetics of amlodipine besilate oral liquid and tablets in healthy Dutch volunteers.
- ACRONYMComparison of the pharmacokinetics of amlodipine besilate oral liquid and tablets
- hypothesisAmlodipine 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.
- Healt Condition(s) or Problem(s) studiedPharmacokinetics, Hypertension, Amlodipine besilate, Oral liquid
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-mrt-2013
- Target number of participants12
- InterventionsAll 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.
- Primary outcomeThe 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 outcomeSecondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to be determined using a questionnaire.
- TimepointsAll 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPh.D, Pharm.D L. Hanff
- CONTACT for SCIENTIFIC QUERIESPh.D, Pharm.D L. Hanff
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-okt-2012 - 12-sep-2013


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