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

November 8, 2005
February 13, 2009
November 2005
Not Provided
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Same as current
Complete list of historical versions of study NCT00251030 on ClinicalTrials.gov Archive Site
To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Same as current
Not Provided
Not Provided
 
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
Drug: Nelfinavir and Omeprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2006
Not Provided

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00251030
A4301024
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Jasper Clinic, Michigan
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP