A Drug-Drug Interaction Study of Warfarin and PA21

A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Warfarin in Healthy Male and Female Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477424

Enrollment

Registered

2011-11-22

Start date

2011-11-30

Completion date

2012-02-29

Last updated

2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interaction Potentiation

Keywords

Drug-drug interaction, Pharmacokinetics, PA21

Brief summary

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

Interventions

DRUGPA21

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

DRUGWarfarin

The maximum dosage of Warfarin will be 10 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * Written informed consent

Exclusion criteria

* No significant medical conditions * Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve from time zero to 24 hours (AUC0-24)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Area Under the Curve from time zero to infinite (AUC0-infinity)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Maximum observed plasma concentration (Cmax)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post Warfarin dose on days 0, 11, 22	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026