A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers

This is an open-label, prospective, randomized, cross-over, single-center trial designed to evaluate the bioavailability, safety, and tolerability of DPH001 compared to Nexavar® in healthy male participants and healthy female participants of non-childbearing potential. The objective of the study is to compare the pharmacokinetics (PK) of sorafenib after the administration of 100 mg DPH001 vs. after the administration of 200 mg Nexavar®. After being informed of the study and potential risks, all subjects given written informed consent will undergo a screening to determine eligibility for study entry. Participants will receive, in a randomized order, 1 dose of 100 mg DPH001, and 1 dose of 200 mg Nexavar®, all in a fasted state. IMP administrations will be separated by wash-out periods of at least 14 days.