Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT03403504
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2016-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
OTR Tablet 10 mg Fasted-state Bioequivalence Study
Sponsor:
Mundipharma (China) Pharmaceutical Co. Ltd
Organization:
Study Overview
Official Title:
An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 10 mg and OXYCONTIN® Tablet 10 mg in Chinese Subjects With Chronic Pain
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single Dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted 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 PK profile of oxycodone from OTR tablet 10 mg and OXYCONTIN tablet 10 mg in Chinese subjects with chronic pain in a fasted state.
the China regulations for drug registration require that controlled medicine (opioid is categorized to be a controlled medicine) should not be applied in healthy volunteers in clinical studies. 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. The subjects with abnormal liver and kidney functions, which may affect the metabolism of oxycodone.
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 period
open label design is applied since the plasma concentration of oxycodone is to be objectively tested and analysed and randomization will be applied to reduce selection bias.
the China regulations for drug registration require that controlled medicine (opioid is categorized to be a controlled medicine) should not be applied in healthy volunteers in clinical studies. 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. The subjects with abnormal liver and kidney functions, which may affect the metabolism of oxycodone.
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 period
open label design is applied since the plasma concentration of oxycodone is to be objectively tested and analysed and randomization will be applied to reduce selection bias.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: