The aim of this study is to assess and compare the pharmacokinetic parameters of the newly developed amlodipine besilate oral liquid 0,5 mg/ml with commercial Norvasc 5 mg tablets. The secondary objective is to assess the taste of the oral liquid.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
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
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 objective
The aim of this study is to assess and compare the pharmacokinetic parameters
of the newly developed amlodipine besilate oral liquid 0,5 mg/ml with
commercial Norvasc 5 mg tablets. The secondary objective is to assess the taste
of the oral liquid.
Study design
The study is conducted as an open-label, single-dose, two-sequence, two-period
crossover design and will be performed at the Erasmus Medical Centre.
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.
Study burden and risks
Each period of this study, participants are exposed to amlodipine, a common
drug used for treatment of hypertension in adults. Since the safety and
efficacy of amlodipine are extensively studied, the occurrence of serious side
effects is expected to be rare. After intake of amlodipine, 14 hour period of
hospitalization of participants is necessary to study the absorption phase
accurately. At baseline and 0,5, 1, 1,5, 2, 2,5, 3, 4, 6, 8, 10, 12, 24, 48 and
72 hours post dose blood samples will be drawn. For safety reasons, blood
pressure and heart rate will be monitored at baseline and 1, 3, 6, 8, 10, 12,
24, 48 and 72 hours post dose. Furthermore, subjects need to fill in a
questionnaire to screen on good health and for assessing the taste of the
investigational product. The possible burden of hospitalization, blood sampling
and blood pressure monitoring subjects can experience, are offset with a
financial compensation.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
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
•Allergy for one of the substances of both formulations
•Pregnancy
•Smoking
•Subject has history of alcohol or drug abuse
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-004065-41-NL |
| CCMO | NL42509.078.12 |