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OpenTrials
Completed

NCT Number: NCT00251030

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfinavir and Omeprazole

Drug

Primary outcomes

  1. To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects

Secondary outcomes

  1. To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Jasper Clinic, Michigan

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Nov 9, 2005
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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