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A Drug-Drug Interaction Study of Omeprazole and PA21

NCT01452906 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-12-12

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

PA21 and Omeprazole with food

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day

DRUG

No PA21; Omeprazole with food

The maximum dosage of Omeprazole will be 40 mg/day

DRUG

PA21 with food, Omeprazole 2hrs later

The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day

Sponsors & Collaborators

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Peter J Winkle, MD · ACRI - Phase 1 (Advanced Clinical Research Institute)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452906 on ClinicalTrials.gov