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NCT Number: NCT01643772

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

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.

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Key information

Conditions

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

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone hydrochloride

Drug

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 names: OxyNorm® Capsules

Primary outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd

Industry

Registry information

Official study title

OxyNorm® Capsules (Immediate-Release) PK Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2012
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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