CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
Oxycodone hydrochloridedrug
Likely dose
Oxycodone hydrochloride 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01643772
NCT01643772Phase 1Completed
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OxyNorm® Capsules (Immediate-Release) PK Study

Mundipharma (China) Pharmaceutical Co. Ltd·interventional·Posted Jul 18, 2012·Updated Oct 21, 2019

In Brief

A Phase 1 clinical trial evaluating Oxycodone hydrochloride for Pain. Completed, enrolled 61 participants across 1 site.

Detailed Summary

A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2012
Enrollment StartMay 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.0 years ago

Interventions

Oxycodone hydrochloridedrug

The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.