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OpenTrials
Completed

NCT Number: NCT01324752

A Drug-Drug Interaction Study of Losartan and PA21

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

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Key information

Conditions

Drug Interaction Potentiation

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ACRI- Phase 1

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Written informed consent

Exclusion criteria

  • No significant medical conditions
  • Pregnancy

Treatment and study plan

PA21 and Losartan with Food

Drug

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

No PA21; Losartan with food

Drug

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

PA21 with food and Losartan 2 hours later

Drug

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

Primary outcomes

  1. Effect of PA21 on Losartan potassium

    Time frame: PK assessment on Day 0, 11, 22

    To assess the effect, if any, of PA21 on Losartan potassium exposure

Secondary outcomes

  1. Effect of PA21 on the active metabolite of Losartan potassium

    Time frame: PK assessment on Day 0, 11, 22

    To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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