NCT03398278

OTR Tablet 40 mg Fasted-state Bioequivalence Study

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Oxycodone Tamper Resistant	Orally taking Oxycodone Tamper Resistant 40mg in fast state
DRUG	OXYCONTIN®	Orally taking OXYCONTIN® 40mg in fast state

Timeline

• Start date: 2017-06-30
• Primary completion: 2017-10-15
• Completion: 2018-03-20
• First posted: 2018-01-12
• Last updated: 2020-01-31
• Results posted: 2019-10-31

Locations

1 site across 1 country: China