NCT03398330

OTR Tablet 40 mg Fed-state Bioequivalence Study

An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fed 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: 42 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain.

Detailed description

The investigation is designed as an open-label, single dose, randomized, and cross-over study to determine the pharmacokinetics(PK) profile of oxycodone from OTR tablet 40 mg and OXYCONTIN tablet 40 mg in Chinese subjects with chronic pain in a fed stat. 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.

Conditions

• Chronic Pain

Interventions

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

Timeline

• Start date: 2017-03-16
• Primary completion: 2017-09-05
• Completion: 2017-11-06
• First posted: 2018-01-12
• Last updated: 2019-11-15
• Results posted: 2019-11-15

Locations

1 site across 1 country: China