Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: atenolol 50 mg

Drug: low sodium diet

Drug: high sodium diet

Drug: candesartan 8 mg

Drug: valsartan 160 mg

Drug: ramipril 10 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT00310778

P051201

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.