Clinical Trials Logo
  1. Home
  2. Biological Availability
  3. NCT05439408

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

Biological Availability Clinical Trial

Official title:
An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Four-Period, Full Replicate, Crossover, Single Dose, Oral Comparative Bioavailability Study of XS004 (Dasatinib) 100 mg Film-Coated Tablets, Formulation G of Xspray Pharma AB, Sweden, and SPRYCEL® (Dasatinib) 140 mg Film-Coated Tablets of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Healthy, Adult Subjects Under Fasting Conditions

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05439408
Study type Interventional
Source Xspray Pharma AB
Contact
Status Completed
Phase Phase 1
Start date June 7, 2021
Completion date June 25, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT05544786 - Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants. Phase 1
Completed NCT04744233 - Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects. N/A
Completed NCT05561075 - Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO) N/A
Completed NCT03873909 - Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit N/A
Completed NCT03353857 - Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam Phase 1
Completed NCT05121506 - A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults Phase 1
Completed NCT01267201 - A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form Phase 1
Completed NCT02538393 - Relative Bioavailability of Sorafenib Tablet for Oral Suspension Phase 1
Completed NCT05116982 - Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL) N/A
Completed NCT04207372 - Protein Digestibility of Whey and Zein. N/A
Completed NCT01853800 - Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet Phase 1
Completed NCT00714584 - Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers Phase 1
Completed NCT04876261 - Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements N/A
Completed NCT03886597 - Nutritional Intervention With Table Olives in Healthy Volunteers Phase 1/Phase 2
Completed NCT06289140 - Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) N/A
Completed NCT03951025 - Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN) Phase 2
Completed NCT03984916 - Study of the Bioavailability of Three Hesperidin Extracts. N/A
Completed NCT02966704 - Stable Isotope Method to Assess Dietary Protein Quality N/A
Completed NCT02847117 - Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults. N/A
Completed NCT03048110 - Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction Phase 1