A Drug-Drug Interaction Study of Losartan and PA21

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01324752

Enrollment

Registered

2011-03-29

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2012-12-21

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 Losartan potassium is affected by PA21.

Interventions

DRUGPA21 and Losartan with Food

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

DRUGNo PA21; Losartan with food

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

DRUGPA21 with food and Losartan 2 hours later

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 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 Losartan potassium	PK assessment on Day 0, 11, 22	To assess the effect, if any, of PA21 on Losartan potassium exposure

Secondary

Measure	Time frame	Description
Effect of PA21 on the active metabolite of Losartan potassium	PK assessment on Day 0, 11, 22	To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium

Countries

United States

Outcome results

None listed

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