A Drug-Drug Interaction Study of Furosemide and PA21

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PA21 and Furosemide with food; Drug: No PA21; Furosemide with food; Drug: PA21 with food and Furosemide 2hrs later

• Registration Number: NCT01438359
• Lead Sponsor: Vifor Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Last Update Submitted: 2011-09-29
• Last Update Posted: 2011-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 Furosemide with food	PA21 and Furosemide with food	-
No PA21; Furosemide with food	No PA21; Furosemide with food	-
PA21 with food and Furosemide 2hrs later	PA21 with food and Furosemide 2hrs later	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

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