Study AP-ADF-108

Product: Acurox® Tablets
Study: AP-ADF-108 or Study 108
Phase: Phase I
Title: A Single-Dose, 4-Period, 4-Treatment, 4-Way Crossover Study of OxyADF(oxycodone HCl and niacin) 5/30 mg Tablets Under Fed and Fasted Conditions

Study Objective

To assess the single dose linearity and food effect of Acurox Tablets

Design Summary

Study 108 is a single-dose, open-label, randomized, 4-period, 4-treatment crossover study in which 28 healthy adult subjects were scheduled to receive 4 separate single-dose administrations of Acurox 5/30mg under fed and fasted conditions. During 3 of the 4 periods, a single dose of Acurox (1, 2, or 3 tablets) was administered following an overnight fast of at least 10 hours. During 1 of the 4 study periods, a single dose of Acurox 5/30 mg (1 tablet) was administered to subjects under fed conditions.

Results Summary

Study 108 confirmed that Acurox Tablets demonstrates single dose linearity and that absorption is delayed by food.