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Completed

NCT Number: NCT00310778

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou

Paris, 75908 Cedex 15, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high sodium diet

Drug

high sodium diet

low sodium diet

Drug

low sodium diet

ramipril 10 mg

Drug

ramipril 10 mg

Valsartan 160 mg

Drug

valsartan 160 mg

candesartan 8 mg

Drug

candesartan 8 mg

Atenolol 50 MG

Drug

atenolol 50 mg

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 4, 2006
Registry last updated
Sep 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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