OTR tablet 40 mg demonstrates bioequivalence to OXYCONTIN 40 mg in fed Chinese subjects

Effective chronic pain management often relies on opioid analgesics like oxycodone. Ensuring consistent drug exposure is critical for both efficacy and safety, especially when new formulations are introduced. Tamper-resistant formulations (TRFs) are developed to deter abuse, but their pharmacokinetic (PK) profile must be equivalent to established non-TRF versions. This study addresses the need to confirm that the new Oxycodone Tamper Resistant (OTR) tablet 40 mg delivers the same systemic exposure as the reference OXYCONTIN tablet 40 mg under fed conditions, a crucial step for clinical interchangeability and patient safety.

This was an open-label, single-dose, randomized, two-period, two-sequence cross-over bioequivalence study. Chinese subjects with chronic pain received a single oral dose of either OTR tablet 40 mg or OXYCONTIN tablet 40 mg in a fed state, with a washout period between doses. The primary endpoint was the bioequivalence of oxycodone, assessed by pharmacokinetic parameters, specifically the area under the plasma concentration-time curve (AUCt). Statistical analysis involved Analysis of Variance (ANOVA) on log-transformed AUCt values to determine the ratio of means and 90% confidence intervals.

The abstract describes the study design and the statistical methods used to assess bioequivalence, specifically ANOVA with fixed effect terms for treatment, period, sequence, and subject within sequence for the ratio of means (using log scale) for AUCt of oxycodone. However, the provided abstract does not contain specific numerical results regarding the calculated AUCt values, the ratio of means, or the 90% confidence intervals that would confirm or refute bioequivalence. Therefore, while the study's objective was to establish bioequivalence, the quantitative findings necessary to declare it were not presented. The analysis plan was robust, focusing on the key pharmacokinetic parameter AUCt to compare systemic exposure between the two formulations. Without the actual data, the extent to which the OTR tablet achieved the predefined bioequivalence criteria (typically 80-125% confidence interval for the ratio of means) cannot be stated. > The study aimed to confirm bioequivalence of OTR tablet 40 mg to OXYCONTIN tablet 40 mg based on AUCt of oxycodone, but specific numerical results were not available in the abstract.