A Drug-Drug Interaction Study of Omeprazole and PA21
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to determine if Omeprazole is affected by PA21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 12, 2011
December 1, 2011
3 months
September 22, 2011
December 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area Under the Curve from time zero to 24 hours (AUC0-24)
Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
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 Curve from time zero to infinite (AUC0-infinity)
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
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
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
Study Arms (3)
PA21 and Omeprazole with food
EXPERIMENTALNo PA21; Omeprazole with food
EXPERIMENTALPA21 with food, Omeprazole 2 hrs later
EXPERIMENTALInterventions
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day
The maximum dosage of Omeprazole will be 40 mg/day
The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day
Eligibility Criteria
You may qualify if:
- Healthy Volunteers
- Written informed consent
You may not qualify if:
- No significant medical conditions
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
Study Sites (1)
ACRI - Phase 1
Anaheim, California, 92801, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Winkle, MD
ACRI - Phase 1 (Advanced Clinical Research Institute)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
October 17, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 12, 2011
Record last verified: 2011-12