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

This study has been completed.
Sponsor:
Collaborator:
Jasper Clinic, Michigan
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00251030
First received: November 8, 2005
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: Nelfinavir and Omeprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

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

Enrollment: 20
Study Start Date: November 2005
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00251030     History of Changes
Other Study ID Numbers: A4301024
Study First Received: November 8, 2005
Last Updated: February 13, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013