Status:
COMPLETED
Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE1
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 ...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00310778
Start Date
March 1 2006
End Date
March 1 2007
Last Update
September 22 2008
Active Locations (1)
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1
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Paris, France, 75908 Cedex 15