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

Official Title: “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”

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.

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • treatment

Primary Measures

• Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
  • Time Frame: 48 hours
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Assistance Publique - Hôpitaux de Paris Other

Overall Clinical Trial Officials and Contacts

Michel Azizi, MD, PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00310778

Study ID Number: P051201

ClinicalTrials.gov Identifier: NCT00310778

Health Authority: France: Ministry of Health