An open-label phase I comparator-controlled clinical trial to assess tolerability and pharmacokinetics of IHL-675 A a fixed dose combination of cannabidiol plus hydroxychloroquine in healthy volunteers

Abstract This was a phase I randomised comparator controlled clinical trial that assessed the pharmacokinetics (PK), and tolerability of IHL-675 A, a fixed dose combination (FDC) of cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ), compared to the reference listed drugs Epidiolex (CBD) and Plaquenil (HCQ) in healthy volunteers (HVs). IHL-675 A is Incannex Healthcare Pty Ltd.’s proprietary product formulated using UniGel™ technology consisting of a solid, film coated HCQ tablet contained within a CBD-oil solution gel cap. Each IHL-675 A gel