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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251030

Enrollment

Registered

2005-11-09

Start date

2005-11-30

Completion date

2006-01-31

Last updated

2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGNelfinavir and Omeprazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026