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OTR Tablet 40 mg Fed-state Bioequivalence Study

NCT03398330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-11-15

Study results available
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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.

Conditions

Interventions

DRUG

Oxycodone Tamper Resistant

Orally taking Oxycodone Tamper Resistant 40mg in fed state

DRUG

OxyContin®

Orally taking OXYCONTIN® 40mg in fed state

Sponsors & Collaborators

  • Mundipharma (China) Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Pingsheng Xu, Master · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2017-09-05
Completion
2017-11-06

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398330 on ClinicalTrials.gov