OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
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|ClinicalTrials.gov Identifier: NCT02880475|
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: OXN PR tablet||Phase 1|
It will be conducted to assess the pharmacokinetics of OXN 5/2.5 and OXN 20/10 tablets. Subjects will be allocated to a sequence of two strength group in accordance with a random allocation schedule (RAS) in a 1:1 ratio.
Subjects will attend a screening visit within 14 days of the first (OXN) dosing day (Day 1).
Eligible subjects will then check into the study unit on the day before OXN dosing (Day -2). Subjects will be administered their OXN dose the next 2 morning (Day 1), following an overnight fast.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomized, Single-dose, Parallel Group Study to Investigate the Pharmacokinetics of Oxycodone and Naloxone From OXN 5/2.5 and OXN 20/10 in Chinese Patients With Moderate to Severe Chronic Non-malignant Pain|
|Actual Study Start Date :||June 1, 2014|
|Actual Primary Completion Date :||June 1, 2015|
|Actual Study Completion Date :||July 10, 2015|
Experimental: OXN prolonged release tablet
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
Drug: OXN PR tablet
Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
Other Name: Targin
- AUC0-t of oxycodone and naloxone plasma concentration at Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h,28h,32h,36h,48h post dose. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed . [ Time Frame: 48 hour blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients. ]Plasma concentrations of oxycodone, noroxycodone, oxymorphone and noroxymorphone, and for naloxone, 6β-naloxol, naloxone-3-glucuronide, and 6β-naloxol-3-glucuronide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880475
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|Study Director:||Victoria YU||Mundipharma (China) Pharmaceutical Co. Ltd|