A Drug-Drug Interaction Study of Furosemide and PA21

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01438359

Enrollment

Registered

2011-09-22

Start date

2011-07-31

Completion date

2011-09-30

Last updated

2011-09-30

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

Conditions

Healthy

Keywords

Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation

Brief summary

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

Interventions

DRUGPA21 and Furosemide with food

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day

DRUGNo PA21; Furosemide with food

The maximum dosage of Furosemide will be 40 mg/day

DRUGPA21 with food and Furosemide 2hrs later

The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 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
Effect of PA21 on Furosemide	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	To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).

Countries

United States

Outcome results

None listed

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