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Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00952913
Enrollment
24
Registered
2009-08-06
Start date
2009-08-31
Completion date
2009-10-31
Last updated
2011-04-19

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

Conditions

Healthy

Brief summary

The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Interventions

DRUGBosutinib

4 x 100-mg oral tablets, single dose

DRUGLansoprazole

2 x 30-mg oral tablets, single daily doses for 2 days

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion criteria

* Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics as measured by Cmax, AUC, tmax, t1/21 month

Countries

United States

Outcome results

None listed

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