Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Jasper Clinic, Michigan
Information provided by:
Pfizer Identifier:
First received: November 8, 2005
Last updated: February 13, 2009
Last verified: February 2009
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
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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00251030

United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Jasper Clinic, Michigan
Study Director: Pfizer Call Center Pfizer
  More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00251030     History of Changes
Other Study ID Numbers: A4301024
Study First Received: November 8, 2005
Last Updated: February 13, 2009

Additional relevant MeSH terms:
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 processed this record on April 28, 2017