Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nilotinib

• Registration Number: NCT00418769
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-08
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Status Verified: 2012-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nilotinib Tablet Formulations	Nilotinib	-
Established Nilotinib Capsule Formulation	Nilotinib	-

Primary Outcome Measures

Name	Time	Method
bioavailability of nilotinib