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OTR Tablet 10 mg Fasted-state Bioequivalence Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

OTR Tablet 10 mg Fasted-state Bioequivalence Study

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

NCT03403504•Mundipharma (China) Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
•2. The average pain over the last 24 hours should be scored \< 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition has been kept stable at least in the past 7 days prior to entering into the screening and is expected to be stable during the study duration
•3. Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
•4. Karnofsky score of Performance Status ≥70
•5. Willing to take all the food supplied while the subject is in the study unit
•6. Be able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and be willing to follow the protocol requirements
•7. Willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, some Intrauterine Device (IUD), sexual abstinence, or vasectomised partner
•8. Female subjects, including those up to less than one year post-menopausal, must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria

•1. Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
•2. Have hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR and OXYCONTIN tablet Summary of Product Characteristics
•3. Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
•4. Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
•5. Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency
•6. Subjects with respiratory depression, corpulmonale, or chronic bronchial asthma
•7. Any history of seizures or symptomatic head trauma
•8. Subjects with abnormal liver function (values exceeding the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin during the Screening Phase) or abnormal renal function (values exceeding the ULN for serum creatinine during the Screening Phase). Note: if the values of ALT, AST or total bilirubin are between 1 to 1.2 times of ULN and confirmed not clinically significant by the Investigators, the subject may be recruited after getting the approval from Sponsor.
•9. Any other significant illness other than the primary disease of chronic pain during the 4 weeks preceding the entry into this study
•10. Subjects who are unable to stop taking monoamine oxidase inhibitors during this trial period or time lapses less than 2 weeks since drug withdrawal prior to the study drug administration
+12 more criteria

Locations (1)

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Key Dates

Start Date

February 1, 2017

Primary Completion Date

July 24, 2017

Completion Date

September 7, 2017

Last Updated

January 31, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Pain

Interventions

Oxycodone Tamper Resistant

DRUG

OXYCONTIN®

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OTR Tablet 10 mg Fasted-state Bioequivalence Study

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