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
  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:


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

ClinicalTrials.gov processed this record on October 23, 2014