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

NCT05439408 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

  • Biological Availability

Interventions

DRUG

Dasatinib ASD 100 mg

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

DRUG

Dasatinib 140 MG [Sprycel]

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

Sponsors & Collaborators

  • QPS Bioserve India Pvt Limited

    collaborator UNKNOWN

  • Xspray Pharma AB

    lead INDUSTRY

Principal Investigators

  • Per Andersson, PhD · Xspray Pharma AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2021-06-25
Completion
2021-06-25
FDA Drug
Yes

Countries

  • India

Study Locations

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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 NCT05439408 on ClinicalTrials.gov