---
title: Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
nct_id: NCT00310778
overall_status: COMPLETED
phase: PHASE1
sponsor: Assistance Publique - Hôpitaux de Paris
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00310778.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00310778"
ct_last_update_post_date: 2008-09-22
last_seen_at: "2026-05-12T06:45:46.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00310778](https://clinicaltrials.gov/study/NCT00310778)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** Assistance Publique - Hôpitaux de Paris
- **Conditions:** Healthy
- **Start Date:** 2006-03
- **Completion Date:** 2007-03
- **CT.gov Last Update:** 2008-09-22

## 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 system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.

## 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 control (ATENOLOL 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 35 Years
- **Sex:** MALE
- **Healthy Volunteers:** 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.
```

## Arms

- **1** (EXPERIMENTAL) — treatment

## Interventions

- **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

- **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)_

## Locations (1)

- Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou, Paris, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre d'investigation clinique 9201 hôpital européen georges pompidou|paris||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00310778.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00310778*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*