A Drug-Drug Interaction Study of Omeprazole and PA21

Phase 1

Completed

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

• Registration Number: NCT01452906
• Lead Sponsor: Vifor Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 Omeprazole with food	PA21 and Omeprazole with food	-
No PA21; Omeprazole with food	No PA21; Omeprazole with food	-
PA21 with food, Omeprazole 2 hrs later	PA21 with food, Omeprazole 2hrs later	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve from time zero to 24 hours (AUC0-24)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole dose on Days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Area Under the Curve from time zero to infinite (AUC0-infinity)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Maximum observed plasma concentration (Cmax)	pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22

Trial Locations

Locations (1)

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