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

This study has been completed.

First Received on November 8, 2005. Last Updated on February 13, 2009 History of Changes

Sponsor:	Pfizer
Collaborator:	Jasper Clinic, Michigan
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00251030

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 IV

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:

Drug Information available for: Omeprazole Omeprazole magnesium Nelfinavir Nelfinavir Mesylate Esomeprazole Sodium Esomeprazole magnesium

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 February 09, 2012