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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xspray Pharma AB
• Collaborator: QPS Bioserve India Pvt Limited
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

• Healthy males (sterile or using contraception) or females of non-childbearing potential 18 and 55 years of age

• Acceptable medical history, physical examination, laboratory investigations within 21 days prior to enrollment

• Clinical laboratory values were within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator

• The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures

Exclusion Criteria:

• Any history of impairment of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or disorder

• Participated in any other clinical study or donated blood in last 90 days

• Positive screens for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody (HepC) or human immunodeficiency virus (HIV)

• Female subjects demonstrating a positive pregnancy screen, currently breastfeeding or using hormone replacement therapy within three months prior to dosing of test product