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Omeprazole capsules |
Prilosec |
Clinical Trial: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
|
Purpose
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects
| Intervention | Phase |
|---|---|
| Drug: Nelfinavir and Omeprazole | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Further study details as provided by Pfizer:
Primary Outcomes: To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Secondary Outcomes: To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Expected Total Enrollment: 20
Secondary Outcomes: To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Expected Total Enrollment: 20
Study start: December 2005
Eligibility
Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00251030
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A4301024
Last Updated: December 8, 2005
Record first received: November 8, 2005
ClinicalTrials.gov Identifier: NCT00251030
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: November 8, 2005
ClinicalTrials.gov Identifier: NCT00251030
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Omeprazole (Drug Digest)
- Prilosec (Drug Digest)
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