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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Atenolol; Candesartan; Candesartan cilexetil; Ramipril; Valsartan

Criteria

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.