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Trial record 15 of 475 for:    CANDOX OR CAREXIL OR OXYCONTIN OR OXYNORM OR RELTEBON OR LEVERAXO OR LONGTEC OR OXAYDO OR SHORTEC OR OXELTRA OR OXYLAN OR ZOMESTINE OR OXYCODONE HYDROCHLORIDE OR ROXYBOND OR ROXICODONE OR LYNLOR OR OXECTA OR ABTARD OR DOLOCODON PR

OTR Tablet 10 mg Fasted-state Bioequivalence Study

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ClinicalTrials.gov Identifier: NCT03403504
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Oxycodone Tamper Resistant Drug: OXYCONTIN® Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 24, 2017
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Oxycodone Tamper Resistant
Oxycodone Tamper Resistant (OTR) Tablet 10 mg
Drug: Oxycodone Tamper Resistant
Orally administered Oxycodone Tamper Resistant 10mg
Other Name: Oxycodone Tamper Resistant (OTR) Tablet 10 mg

Active Comparator: OXYCONTIN®
OXYCONTIN® Tablet 10 mg
Drug: OXYCONTIN®
Orally administered OXYCONTIN® Tablet 10 mg
Other Name: OXYCONTIN® Tablet 10 mg




Primary Outcome Measures :
  1. To confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state. [ Time Frame: up to 32 hours ]
    The primary analysis will be for PK parameter AUCt for analyte oxycodone. ANOVA with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) will be used to compare the test and the reference treatments.

  2. To confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state [ Time Frame: up to 32 hours ]
    The primary analysis will be for PK parameter Cmax for analyte oxycodone. ANOVA with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) will be used to compare the test and the reference treatments.

  3. To confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state [ Time Frame: up to 32 hours ]
    The primary analysis will be repeated for the PK parameter AUCINF for analyte oxycodone


Secondary Outcome Measures :
  1. To assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg, when given to Chinese subjects with chronic pain in a fasted state [ Time Frame: up to 35 days ]
    An overall summary of the number and percentage of Adverse Events will be provided by treatment groups.

  2. To assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg, when given to Chinese subjects with chronic pain in a fasted state [ Time Frame: up to 35 days ]
    Clinical laboratory data (hematology, blood chemistry, and urinalysis) to be summarised on the rate of lower than, within, and higher than the reference range values from baseline to end of study.

  3. To assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg, when given to Chinese subjects with chronic pain in a fasted state [ Time Frame: up to 35 days ]
    Vital sign parameters( systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature)to be summarised on the rate of lower than, within, and higher than the reference range values from baseline to end of study.

  4. To assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg, when given to Chinese subjects with chronic pain in a fasted state [ Time Frame: up to 35 days ]
    Clinically significant ECG findings as determined by the Investigators will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  11. Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the study drug administration
  12. 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
  13. 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
  14. 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.
  15. 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)
  16. Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol for at least 48 hours after study drug administration
  17. Refusal to abstain from food for 10 hours preceding and 4 hours following administration of the study drug and to abstain from caffeine or xanthine entirely during each confinement
  18. Positive Hepatitis B Surface Antigen (HBsAg), anti-Hepatitis C Virus (HCV), anti-Human Immunodeficiency Virus (HIV), or syphilis antibody test result
  19. Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids. Or alcohol breath test is positive
  20. Any history of frequent nausea or emesis regardless of aetiology
  21. Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol
  22. Subjects who participated in a clinical research study within 30 days of study entry

Information from the National Library of Medicine

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): NCT03403504


Locations
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China, Liaoning
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Sponsors and Collaborators
Mundipharma (China) Pharmaceutical Co. Ltd
Investigators
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Principal Investigator: Wenping Wang First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

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Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT03403504     History of Changes
Other Study ID Numbers: ONF16-CN-101
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Oxycodone
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents