|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00814060 |
Purpose
This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: HKI-272 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects |
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
40-mg tablet
|
Drug: HKI-272 |
|
2: Experimental
240-mg tablet
|
Drug: HKI-272 |
|
3: Experimental
80-mg capsule
|
Drug: HKI-272 |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Healthy male and female subjects, ages 18-50.
Contacts and Locations| Contact: Trial Manager | clintrialparticipation@wyeth.com |
| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3144A1-1117 |
| Study First Received: | December 17, 2008 |
| Last Updated: | December 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00814060 |
| Health Authority: | United States: Food and Drug Administration |
|
Healthy |
