Healthy
Conditions
Keywords
High sodium diet, Low sodium diet, Renin-angiotensin system blockers, AT1 receptor (AT1R) antagonist, ACE inhibition
Brief summary
The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.
Detailed description
The impact of sodium intake on plasma drug concentrations concentrations obtained after a single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg) or a blocker as control (ATENOLOL 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.
Interventions
DRUGhigh sodium diet
high sodium diet
DRUGlow sodium diet
low sodium diet
DRUGramipril 10 mg
ramipril 10 mg
DRUGvalsartan 160 mg
valsartan 160 mg
DRUGcandesartan 8 mg
candesartan 8 mg
DRUGatenolol 50 mg
atenolol 50 mg
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 64 (16 per treatment goup) non-smoking healthy male volunteers * Aged between 18 and 35 years after a complete clinical examination * Safety laboratory measurements * Having given written informed consent.
Exclusion criteria
* hypertension * known disease * diabetes mellitus * known hypersensitivity * contraindication to ACE inhibitors * history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion | 48 hours |
Countries
France
Outcome results
None listed