Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2011-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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PA21 and Omeprazole with food
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
No PA21; Omeprazole with food
No PA21; Omeprazole with food
The maximum dosage of Omeprazole will be 40 mg/day
PA21 with food, Omeprazole 2 hrs later
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
Interventions
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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
No PA21; Omeprazole with food
The maximum dosage of Omeprazole will be 40 mg/day
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
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Pregnancy
20 Years
50 Years
ALL
Yes
Sponsors
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Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Peter J Winkle, MD
Role: PRINCIPAL_INVESTIGATOR
ACRI - Phase 1 (Advanced Clinical Research Institute)
Locations
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ACRI - Phase 1
Anaheim, California, United States
Countries
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Other Identifiers
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PA-DDI-003
Identifier Type: -
Identifier Source: org_study_id