Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SKI-606 (Bosutinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080365

3160A4-1120

B1871016

Details and patient eligibility

About

Study comparing 2 formulations of bosutinib in healthy subjects.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men or women of nonchildbearing potential age 18 to 50 years

Exclusion criteria

• Any clinically significant medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

1

Experimental group

Description:

Commercial Tablet

Treatment:

Drug: SKI-606 (Bosutinib)

Drug: SKI-606 (Bosutinib)

2

Experimental group

Description:

Clinical Tablet

Treatment:

Drug: SKI-606 (Bosutinib)

Drug: SKI-606 (Bosutinib)