Study AP-ADF-109

Product: Acurox® Tablets
Study: AP-ADF-109 or Study 109
Phase: Phase I
Title: A Multiple-Dose, Randomized, Open-Label, Two-Way Crossover Pharmacokinetic Study of Acurox (oxycodone HCl and niacin) Tablets, 5 mg/30 mg to Assess the Dose Proportionality of 5 mg and 10 mg Doses of Oxycodone HCl Administered Orally to Healthy Volunteers under Fasting Conditions

Study Objective

To assess the mutliple dose linearity of Acurox Tablets

Design Summary

Study 109 is a multiple-dose, open-label, randomized, two-period crossover study in which 26 healthy subjects were scheduled to receive a dose every six hours for 84 hours (15 doses) with Acurox (oxycodone HCl and niacin) Tablets, 1 × 5 mg/30 mg in one study period and Acurox (oxycodone HCl and niacin) Tablets, 2 × 5 mg/30 mg in another study period.

Results Summary

Study 109 confirmed that Acurox Tablets demonstrates multiple dose linearity.