U.S., March 4 -- ClinicalTrials.gov registry received information related to the study (NCT07445464) titled 'An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers' on Feb. 21.
Brief Summary: This study will assess the pharmacokinetics (PKs), safety and tolerability of ASP-001 in healthy volunteers. ASP-001 is an orally disintegrating tablet (ODT) formulation of flunarizine. This study will assess two formulations, Formulation A and Formulation B, at dose levels of 2 and 5 mg compared to the reference product, the Sibelium brand of flunarizine 5 mg tablet.
Whilst this is not a first-in-human (FIH) study of flunarizine, which is available in countries outside of Australia and has been studied extensively, it is a...