clinical trial · NCT05967377
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
PharmacokineticsBioavailabilitySorafenib - Period 1XS005 Sorafenib Capsule A - Period 1XS005 Sorafenib Tablet A - Period 1XS005 Sorafenib Capsule A - Period 2XS005 Sorafenib Tablet A - Period 2Sorafenib - Period 2XS005 Sorafenib Tablet A - Period 3Sorafenib - Period 3
brief summary
This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.
started
Nov 16, 2018
primary completion
Feb 12, 2019
completion
Feb 12, 2019
last updated
Aug 1, 2023
official title
A Single Part, Open-Label, Randomised, Three-Way Crossover Study Designed to Evaluate the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib From Sorafenib (XS005) Tablets and Capsules Compared With Nexavar® (Reference Product) in Healthy Male Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol