OTR Tablet 10 mg Bioequivalence to OXYCONTIN 10 mg Explored in Fasted Chinese Subjects

Effective management of chronic pain often relies on opioid analgesics like oxycodone. However, the potential for abuse and misuse of these medications necessitates the development of safer formulations. Tamper-resistant (TR) formulations are designed to deter common methods of abuse, such as crushing or dissolving, thereby reducing the risk of diversion and overdose. For a new TR formulation to be clinically viable, it must demonstrate bioequivalence to its established counterpart, ensuring comparable drug exposure and therapeutic effect. This study addresses the critical need to confirm that the Oxycodone Tamper Resistant (OTR) tablet delivers oxycodone similarly to the widely used OXYCONTIN tablet.

This was an open-label, single-dose, randomized, cross-over study designed to confirm the bioequivalence of OTR tablet 10 mg and OXYCONTIN tablet 10 mg. The study was conducted in Chinese subjects experiencing chronic pain, with each participant receiving both formulations in a randomized sequence. The primary objective was to determine the fasted-state pharmacokinetics of oxycodone from both tablets. Pharmacokinetic (PK) parameters, specifically the area under the plasma concentration-time curve (AUCt) of the analyte oxycodone, were measured. The study design involved a single dose administration, followed by a wash-out period, before administration of the alternative formulation, all under fasted conditions.

The study aimed to confirm bioequivalence by analyzing key pharmacokinetic parameters. The primary analysis focused on the AUCt of oxycodone. Statistical evaluation involved an Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence. This ANOVA was applied to the ratio of means (using a log scale) for the AUCt values to determine if the two formulations delivered comparable systemic exposure to oxycodone. However, the provided abstract does not report the actual results of this analysis, such as the calculated ratio of means, confidence intervals, or whether the pre-defined bioequivalence criteria were met for OTR tablet 10 mg compared to OXYCONTIN tablet 10 mg. Therefore, it is not possible to state specific numerical findings or confirm bioequivalence from the available information.

The study's core objective was to statistically compare the systemic exposure of oxycodone from OTR tablet 10 mg and OXYCONTIN tablet 10 mg via AUCt ratios.