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OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

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ClinicalTrials.gov Identifier: NCT01643772
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

Study Description
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Brief Summary:
A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone hydrochloride Phase 1

Detailed Description:

Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.

Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OxyNorm® Capsules (Immediate-Release) PK Study
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Oxycodone Hydrochloride 5 mg Capsules
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
 Drug: Oxycodone hydrochloride
The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other Name: OxyNorm® Capsules
Experimental: Oxycodone Hydrochloride 10 mg Capsules
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
 Drug: Oxycodone hydrochloride
The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other Name: OxyNorm® Capsules
Experimental: Oxycodone Hydrochloride 20 mg Capsules
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
 Drug: Oxycodone hydrochloride
The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other Name: OxyNorm® Capsules
Experimental: Oxycodone Hydrochloride 10 mg Capsules(multi-dose)
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
 Drug: Oxycodone hydrochloride
The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other Name: OxyNorm® Capsules


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-t and AUC0-∞ for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.

  2. Cmax,Clast for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  3. Tmax,t1/2 for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  4. Clearance Rate for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  5. Vd for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  6. ke for Participants Who Received a Single Dose [ Time Frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]
    To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.

  7. AUCss for Participants Who Received Multiple Dose [ Time Frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. ]
    To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  8. Css_min,Css_max and Css_av for Participants Who Received Multiple Dose [ Time Frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. ]
    To calculate Css_min,Css_max and Css_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  9. Tmax,t1/2 for Participants Who Received Multiple Dose [ Time Frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. ]
    To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  10. CL for Participants Who Received Multiple Dose [ Time Frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. ]
    To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  11. Fluctuation Index (DF) for Participants Who Received Multiple Dose [ Time Frame: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. ]
    To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

  12. The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose) [ Time Frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h ]
    The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  13. Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose) [ Time Frame: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h ]
    Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  14. Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose) [ Time Frame: post dose 24h ]
    Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.

  15. The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose) [ Time Frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day ]
    The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.

  16. Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose) [ Time Frame: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day ]
    Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
  • Patients aged >≥30 to ≤ 60 years;
  • Body weight ≥ 45kg, and BMI range ≥19, <24;
  • Karnofsky score ≥ 70;
  • The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
  • The electrocardiogram examination results are normal;
  • Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

  • Have hypersensitivity history to any opioids;
  • Have known hypersensitivity to any of compositions of the study drugs;
  • Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
  • Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
  • Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
  • Patients with hypercarbia;
  • Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
  • Patients with alcoholism or drug abuse history;
  • Positive anti-HIV or syphilis antibody test result;
  • Patients who are pregnant, or lactating;
  • Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
  • Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
  • Subjects who participated in a clinical research study within one month of study entry;
  • Patients who are currently taking opioids.
Contacts and Locations
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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): NCT01643772


Locations
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China
Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army
Beijing, China
Sponsors and Collaborators
Mundipharma (China) Pharmaceutical Co. Ltd
Investigators
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Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
More Information
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Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01643772    
Other Study ID Numbers: OXYC09-CN-102
First Posted: July 18, 2012    Key Record Dates
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents