A Drug-Drug Interaction Study of Losartan and PA21

Phase 1CompletedNCT01324752

Vifor Pharma36 enrolled

Overview

The purpose of this study is to determine if Losartan potassium is affected by PA21.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.

The maximum dose of Losartan will be 100 mg/day.

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers * Written informed consent Exclusion Criteria: * No significant medical conditions * Pregnancy

ACRI- Phase 1

Anaheim, California, United States

Effect of PA21 on Losartan potassium

To assess the effect, if any, of PA21 on Losartan potassium exposure

Time frame: PK assessment on Day 0, 11, 22

Effect of PA21 on the active metabolite of Losartan potassium

To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium

Time frame: PK assessment on Day 0, 11, 22

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