NCT07138378

A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions.

An Open-label, Randomized, Four-treatment, Four-period, Four-sequence, Single Dose, Crossover Study to Evaluate the Dose Adjusted Relative Bioavailability of Nilotinib Following the Oral Administration of Tasigna 200 mg Capsules, Tasigna 400 mg, XS003 (Nilotinib) Capsules 96mg and 192mg in Healthy, Adult Subjects Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Xspray Pharma AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, single-center, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, comparative bioavailability study in healthy, adult, human subjects under fasteding conditions

Detailed description

To evaluate the relative bioavailability of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	XS003 (nilotinib)	To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg).
DRUG	Tasigna (nilotinib)	To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg).

Timeline

• Start date: 2024-11-15
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: India