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

Phase 4
Completed
Conditions
Healthy Volunteers
Registration Number
NCT00251030
Lead Sponsor
Pfizer
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Healthy male or female subjects between the ages of 18 and 55 years.
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Exclusion Criteria
  • Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Secondary Outcome Measures
NameTimeMethod
To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole

Trial Locations

Locations (1)

Pfizer Investigational Site

🇺🇸

Kalamazoo, Michigan, United States

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