Assessment of comparative bioavailability of Itraconazole capsule 100 mg under fasting conditions by average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE) approaches

  • Francis Micheal Department of Chemistry, School of Advanced Sciences, VIT University, Vellore-632014, Tamil Nadu, India
  • Balamurali MM Department of Chemistry, School of Advanced Sciences, VIT University, Vellore-632014, Tamil Nadu, India
  • Mohanlal Sayana Department of Pharmacokinetic and Drug Metabolism, Strides Arcolab Limited, Bangalore-560076, Karnataka, India
  • Rajendra Prasad M Jeevan Scientific Technology Limited, Hyderabad-500008, Telangana, India

Abstract

The assessment of interchangeability (prescribability and switchability) is one of the debatable topics in the generic drug industry. Currently, the question is whether we have an adequate assessment system for the evaluation of generic drug products. The objective of the study is to assess the comparative oral bioavailability of Itraconazole capsule 100mg after administering single dose to adult, healthy, human subjects in fasted state by different bioequivalence approaches like  average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE) and to monitor the safety of study subjects. An open-label, balanced, randomized, two-treatment, two-sequence, four-period, crossover, single-dose comparative oral bioavailability study was conducted in sixteen healthy, adult, human subjects in a fasted state. Test formulation, Itraconazole capsule 100mg, and reference formulation, SPORANOX®  (Itraconazole) capsule 100mg, were administered in a fasted state. The test formulation, Itraconazole capsule 100mg, showed bio-inequivalent against reference SPORANOX®  (Itraconazole) capsule 100mg in study subjects under a fasted state. Also, the test formulation exhibited a similar safety and tolerability profile compared to the reference formulation. There was no report of serious adverse events (SAEs) and deaths in the study. The test formulation was found to be bio-inequivalent to reference formulation in the study subjects under a fasted state by estimating different bioequivalence approaches like average bioequivalence, population bioequivalence, and individual bioequivalence.

Keywords: Itraconazole, average bioequivalence, population bioequivalence, individual bioequivalence, fasted state

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Published
2019-10-16
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How to Cite
Francis Micheal, Balamurali MM, Mohanlal Sayana, & Rajendra Prasad M. (2019). Assessment of comparative bioavailability of Itraconazole capsule 100 mg under fasting conditions by average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE) approaches. International Journal of Research in Pharmaceutical Sciences, 10(4), 3339-3345. https://doi.org/10.26452/ijrps.v10i4.1643
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Original Articles
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