OTR Tablet 40 mg Fasted-state Bioequivalence Study

Chronic Pain Clinical Trial

Official title: An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain

Status Completed

Clinical Trial Summary

This is an open-label, single dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in Chinese subjects with chronic pain

Clinical Trial Description

In this BE study, subjects with histories of chronic pain are chosen as the target population.

Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data.

Single dose design is chosen per Food and Drug Administration (FDA)/WHO guideline on bioavailability (BA)/BE studies for modified-release products.

As a general rule, cross-over design is applied in the study to decrease the inter-individual variations between the two cohorts. A washout period lasting for at least 7 half-lives of the investigational medicine is needed to eliminate the drug residual from the previous period7. The elimination half-life of oxycodone from OTR is 4.5 hours, and a 6-day washout period is sufficient to achieve the aim. ;

Related Conditions & MeSH terms

• Chronic Pain

• NCT number: NCT03398278
• Study type: Interventional
• Source: Mundipharma (China) Pharmaceutical Co. Ltd
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2017
• Completion date: March 20, 2018