Status:
COMPLETED
Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions
Lead Sponsor:
Xspray Pharma AB
Collaborating Sponsors:
QPS Bioserve India Pvt Limited
Conditions:
Biological Availability
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05439408
Start Date
June 7 2021
End Date
June 25 2021
Last Update
June 30 2022
Active Locations (1)
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1
QPS Bioserve India Pvt Limited
Hyderabad, India, 500037