A Drug-Drug Interaction Study of Furosemide and PA21

Phase 1CompletedNCT01438359

Vifor Pharma42 enrolled

Overview

The purpose of this study is to determine if Furosemide 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 Furosemide will be 40 mg/day

The maximum dosage of Furosemide will be 40 mg/day

The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 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 Furosemide

To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).

Time frame: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose

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