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A Drug-Drug Interaction Study of Omeprazole and PA21

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01452906
First Posted: October 17, 2011
Last Update Posted: December 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vifor Inc.
  Purpose
The purpose of this study is to determine if Omeprazole is affected by PA21.

Condition Intervention Phase
Healthy Drug: PA21 and Omeprazole with food Drug: No PA21; Omeprazole with food Drug: PA21 with food, Omeprazole 2hrs later Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Area Under the Curve from time zero to 24 hours (AUC0-24) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]

Enrollment: 45
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 and Omeprazole with food 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
Experimental: No PA21; Omeprazole with food Drug: No PA21; Omeprazole with food
The maximum dosage of Omeprazole will be 40 mg/day
Experimental: PA21 with food, Omeprazole 2 hrs later 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452906


Locations
United States, California
ACRI - Phase 1
Anaheim, California, United States, 92801
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Peter J Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
  More Information

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01452906     History of Changes
Other Study ID Numbers: PA-DDI-003
First Submitted: September 22, 2011
First Posted: October 17, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Vifor Inc.:
Drug-drug interaction
Pharmacokinetics
PA21
Drug Interaction Potentiation

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action