A Drug-Drug Interaction Study of Digoxin and PA21

Phase 1CompletedNCT01477411

Vifor Pharma42 enrolled

Overview

The purpose of this study is to determine if Digoxin 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 dosage of Digoxin will be 0.5 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

Area Under the Curve from time zero to 24 hours (AUC0-24)

Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours

Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22

Area Under the Curve from time zero to infinite (AUC0-infinity)

Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time

Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22

Maximum observed plasma concentration (Cmax)

Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22

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