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

NCT07138378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-08-22

No results posted yet for this study

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Xspray Pharma AB

    lead INDUSTRY

Principal Investigators

  • Maria Klockare · Xspray Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138378 on ClinicalTrials.gov