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A Drug-Drug Interaction Study of Omeprazole and PA21

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01452906
First received: September 22, 2011
Last updated: December 8, 2011
Last verified: December 2011
History of Changes

September 22, 2011
December 8, 2011
September 2011
December 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01452906 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

The purpose of this study is to determine if Omeprazole is affected by PA21.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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
  • Experimental: PA21 and Omeprazole with food
    Intervention: Drug: PA21 and Omeprazole with food
  • Experimental: No PA21; Omeprazole with food
    Intervention: Drug: No PA21; Omeprazole with food
  • Experimental: PA21 with food, Omeprazole 2 hrs later
    Intervention: Drug: PA21 with food, Omeprazole 2hrs later
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01452906
PA-DDI-003
No
Vifor Inc.
Vifor Inc.
Not Provided
Principal Investigator: Peter J Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
Vifor Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP