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drugset / Trial / NCT05967377

Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

NCT05967377 ↗

Phase 1 Completed 15 enrolled Xspray Pharma AB
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2018-11-16
Primary completion
2019-02-12
Completion
2019-02-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sorafenib Small molecule 100 mg Oral
Comparator Sorafenib Small molecule 200 mg Oral

Indications

No indication recorded.