drugset / Trial / NCT05439408
Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions
RandomizedCrossoverOpen-labelOther
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.
Timeline
- Start
- 2021-06-07
- Primary completion
- 2021-06-25
- Completion
- 2021-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dasatinib anhydrous | Small molecule | 100 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 140 mg | Oral |
Indications
No indication recorded.