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

Completed
Conditions
Pharmacokinetics, hypertension, amlodipine besilate, oral liquid. Farmacokinetiek, hypertensie, amlodipine besilaat, orale drank.
Registration Number
NL-OMON23706
Lead Sponsor
Erasmus Medical Centrees Gravendijkwal 230, 3015 CE Rotterdam, The NetherlandsPhone: +31(0) 10-7040704
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

1. Subject is healthy;

2. Subject is Caucasian;

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;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Measures
NameTimeMethod
Secondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to be determined using a questionnaire.
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