OTR Tablet 40 mg Fed-state Bioequivalence Study

NCT03398330 | Completed Phase 1 Results

• 1 other identifier: ONF16-CN-103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

  The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.

  up to 32 hours

• AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

  The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.

  up to 32 hours

• AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

  The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.

  up to 32 hours

Secondary Outcomes (5)

• Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State

  up to 35 days

• Number of Lab Tests With Clinical Significance

  up to 35 days

• Number of AEs Related to Vital Signs

  up to 35 days

• Number of AEs Related to ECGs

  up to 35 days

• Number of AEs Related to Physical Examination

  up to 35 days

Study Arms (2)

Oxycodone Tamper Resistant

EXPERIMENTAL

Oxycodone Tamper Resistant (OTR) Tablet 40 mg

Drug: Oxycodone Tamper Resistant

OXYCONTIN®

ACTIVE COMPARATOR

OXYCONTIN® Tablet 40 mg

Drug: OxyContin®

Interventions

Oxycodone Tamper Resistant DRUG

Orally taking Oxycodone Tamper Resistant 40mg in fed state

Also known as: Oxycodone Tamper Resistant (OTR) Tablet

Oxycodone Tamper Resistant

OxyContin® DRUG

Orally taking OXYCONTIN® 40mg in fed state

Also known as: OXYCONTIN® Tablet 40 mg

OXYCONTIN®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
• 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
• Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
• Karnofsky score of Performance Status ≥70
• Willing to take all the food supplied while the subject is in the study unit
• Be able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and be willing to follow the protocol requirements
• 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
• Female subjects, including those up to less than one year post-menopausal, must have a negative serum pregnancy test and be non-lactating

You may not qualify if:

• Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
• 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
• Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
• Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
• Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency
• Subjects with respiratory depression, corpulmonale, or chronic bronchial asthma
• Any history of seizures or symptomatic head trauma
• 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.
• Any other significant illness other than the primary disease of chronic pain during the 4 weeks preceding the entry into this study
• 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
• Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the study drug administration
• Subjects who have used any medicinal product which inhibits Cytochrome P450 3A4 (CYP3A4) (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin, etc.) within 4 weeks prior to the study drug administration
• Subjects who have used any medicinal product which inhibits Cytochrome P450 2D6 (CYP2D6) (e.g. fluoxetine, quinidine, ritonavir, etc.) or induces CYP2D6 (e.g. dexamethasone, rifampicin, glutethimide, etc.) within 4 weeks prior to the study drug administration
• Histories of smoking (being a smoker or an occasional smoker) within 45 days prior to the study drug administration and refusal to abstain from smoking during the study. According to World Health Organization (WHO), a smoker is defined as having smoked at least 1 cigarette per day continuously for more than 6 months and an occasional smoker is defined as having smoked for more than 4 times per week and less than 1 cigarette per day continuously for more than 6 months.
• Subjects with histories of alcoholism or drug abuse. Alcoholism is defined as regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Receptors, Oxytocin; Tablets; Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neuropeptide; Receptors, Neurotransmitter; Receptors, Peptide; Receptors, Pituitary Hormone; Dosage Forms; Pharmaceutical Preparations; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Rongna. A
• Organization: Mundipharma(China) Pharmaceutical. Co. Ltd

rongna.a@mundipharma.com.cn

86 10 65636885

Study Officials

• Pingsheng Xu, Master

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: January 12, 2018
• Study Start: March 16, 2017
• Primary Completion: September 5, 2017
• Study Completion: November 6, 2017
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)