A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nelfinavir and Omeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy
subjects
Clinical Details
Official title: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Primary outcome: To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Secondary outcome: To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Kalamazoo, Michigan 49007, United States
Additional Information
Link to ClinicalStudyResults.org posting
Starting date: November 2005
Ending date: December 2005
Last updated: February 1, 2008
|
