Overview

Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions

Status:
Completed

Trial end date:
2021-06-25

Target enrollment:

Participant gender:

Summary

An open label, single-center, balanced, randomized, two-treatment, two-sequence, four-period, full replicate, crossover, single dose, Phase I, oral comparative bioavailability study in healthy, adult participants (male subjects and female subjects of non-childbearing potential) under fasting conditions with a screening period of 21 days prior to enrollment. In each study period, 21 blood samples were collected from each participant to analyze the pharmacokinetic profile of the test as well as the reference drug.

Phase:

Phase 1

Details

Lead Sponsor:

Xspray Pharma AB

Collaborator:

QPS Bioserve India Pvt Limited

Treatments:

Dasatinib