Effects of Sodium Intake on Pharmacokinetic/Pharmacodynamic Relationship of a Single Dose of a Renin Angiotensin System-Blocker, or a Beta-Blocker in Normotensive Sodium-Depleted or Replated Volunteers in a Cross-Over Study

NCT00310778 Phase 1 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1
Status	COMPLETED
Enrolment	64
Start date	2006-03
Completion	2007-03

Conditions

• Healthy

Interventions

• high sodium diet
• low sodium diet
• ramipril 10 mg
• valsartan 160 mg
• candesartan 8 mg
• atenolol 50 mg

Primary outcomes

• 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