Safety and pharmacokinetic comparison between fenofibric acid 135 mg capsule and 110 mg enteric-coated tablet in healthy volunteers

This randomized, crossover Phase I trial compared the pharmacokinetics and safety of a 110-mg fenofibric acid enteric-coated tablet against a 135-mg reference capsule under fasting and fed conditions in healthy Korean men, with pharmacokinetic parameters calculated using Phoenix WinNonlin. The enteric-coated tablet showed higher relative bioavailability than the capsule under both conditions, with peak concentration delayed by one to three hours depending on food status. The smaller, more bioavailable enteric-coated tablet may offer improved bioavailability and easier swallowing for patients compared with the standard capsule formulation.