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Effect of High- and Low-sodium Intake on the Pharmacokinetics and Pharmacodynamic Effects of Fimasartan

NCT02147704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-07-01

No results posted yet for this study

Summary

It has been known that the blood pressure lowering effect of angiotensin receptor antagonists (ARBs) and angiotensin converting enzyme (ACE) inhibitors is impaired in patients on high sodium intake. There was an enhanced blood pressure lowering effect of ACE inhibitor when sodium intake was restricted or diuretics were added.

The reason is partially explained by sodium sensitivity or low rennin activity in high sodium intake. However, the exact mechanism of sodium intake dependency is not clearly understood.

In a recent study, an ARB, candesartan was revealed to have sodium intake dependency, showing lower plasma concentration when subjects were on high sodium intake compared to on low sodium intake. However, plasma concentration of another ARB, valsartan and an ACE inhibitor ramipril was not changed depending on the sodium intake.

The strongly suggested mechanism is the involvement of transporter P-glycoprotein (Pg-P). the function and expression of Pg-P are modified by genetic polymorphism of multidrug resistance 1 gene.

Although the transport mechanism of Fimasartan from gut is not fully understood, it has been known that the multidrug resistance 1 is not involved. Thus, the pharmacokinetic and pharmacodynamic property of fimasartan is expected not to be affected by the status of sodium intake.

The present study is designed to investigate whether the pharmacokinetic and pharmacodynamic property of fimasartan is changed depending on the sodium intake.

Conditions

Interventions

DIETARY_SUPPLEMENT

High-sodium diet

1. One of high- or low sodium intake for 7 days during each period 2. High sodium intake: 50 mmol/day by diet + 250 mmol/day by salt tablets

DIETARY_SUPPLEMENT

low-sodium diet

1. One of high- or low sodium intake for 7 days during each period 2. Low sodium intake : 50 mmol/day by diet

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • DongGuk University

    lead OTHER

Principal Investigators

  • Moo-Yong Rhee, MD, PhD · Clinical Trial Center, Dongguk University Ilsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147704 on ClinicalTrials.gov