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A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT00251030
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : February 16, 2009
Sponsor:
Collaborator:
Jasper Clinic, Michigan
Information provided by:
Pfizer

Brief Summary:
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Nelfinavir and Omeprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Study Start Date : November 2005
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects between the ages of 18 and 55 years.

Exclusion Criteria:

  • Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

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): NCT00251030


Locations
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Pfizer
Jasper Clinic, Michigan
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00251030     History of Changes
Other Study ID Numbers: A4301024
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Omeprazole
Nelfinavir
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents