Purpose: To evaluate the comparative oral bioavailability of Itraconazole capsule 100mg upon administering single dose to adult, healthy, human subjects in fed state by different bioequivalence approaches like average bioequivalence, population bioequivalence and individual bioequivalence and to monitor the safety of subjects upon administration of test and reference formulations. Methods: An open label, balanced, randomized, two-treatment, two-sequence, four-period (fully replicated), crossover, single dose comparative oral bioavailability study was conducted in 16 healthy, adult, human subjects in fed state. Test product, Itraconazole capsule 100mg and reference product, SPORANOX® (Itraconazole) capsule 100mg were administered in fed state. Findings: The test product, Itraconazole capsule 100mg showed bioequivalence against reference product, SPORANOX® (Itraconazole) capsule 100mg in healthy subjects under fed state. Also, the test product exhibited similar safety and tolerability profile compared to reference product. There were no reports of serious adverse events and deaths in the course of study conduct. Conclusions: The test product was found to be bioequivalent to reference product in healthy human subjects under fed state by evaluating different bioequivalence approaches like average bioequivalence, population bioequivalence and individual bioequivalence. © 2017 Pharmainfo Publications. All rights reserved.