|Study:||AP-ADF-104 or Study 104|
|Title:||A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Pharmacokinetic Comparison of Acura Pharmaceuticals, Inc. Acurox® 5/30 mg Tablets with that of Roxane Laboratories, Inc. Roxicodone® 15 mg Tablets Under Fasting Conditions|
To determine the bioequivalence for Acurox Tablets compared to the FDA reference listed drug, Roxicodone® tablets.
Using tablets from batches manufactured in our Culver Facility at a scale of sufficient size to fulfill the FDA’s requirements for a 505(b)(2) NDA submission, Study 104 was a pivotal, single dose, open label, randomized, two period crossover bioequivalence study conducted under fasting conditions to compare the pharmacokinetic characteristics of Acurox (oxycodone HCl/niacin) Tablets 5/30mg to the FDA reference listed drug, Roxicodone tablets,15 mg. Subjects received two separate drug administrations in assigned periods, one treatment per period, according to a randomization schedule. Dosing days were separated by a washout period of at least 7 days. An equal number of subjects were randomly assigned to each possible sequence of treatments. Drug administration consisted of an oral dose of 3 x Acurox® Tablets 5/30mg or 1 x Roxicodone tablet 15mg.
Thirty nine (39) of forty (40) healthy adult subjects completed the study. The results demonstrated that Acurox Tablets are bioequivalent to Roxicodone tablets. The 90% confidence intervals for peak exposure based on ln(Cmax) and overall systemic exposure based on ln(AUClast) and ln(AUCinf) of oxycodone were well within the FDA’s acceptable range for bioequivalence.
Roxicodone® is a registered trademark of Xanodyne Pharmaceuticals, Inc.