A Drug-Drug Interaction Study of Losartan and PA21

Phase 1

Completed

• Conditions: Drug Interaction Potentiation
• Interventions: Drug: PA21 and Losartan with Food; Drug: No PA21; Losartan with food; Drug: PA21 with food and Losartan 2 hours later

• Registration Number: NCT01324752
• Lead Sponsor: Vifor Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy volunteers
• Written informed consent

Exclusion Criteria

• No significant medical conditions
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PA21 and Losartan with food	PA21 and Losartan with Food	-
No PA21; Losartan with food	No PA21; Losartan with food	-
PA21 with food and Losartan 2 hrs later	PA21 with food and Losartan 2 hours later	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ACRI- Phase 1; 🇺🇸 Anaheim, California, United States