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

OxyNorm® Capsules (Immediate-Release) 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone hydrochloride

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: OxyNorm® Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t and AUC0-∞ for Participants Who Received a Single 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.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Cmax,Clast for Participants Who Received a Single Dose	To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Tmax,t1/2 for Participants Who Received a Single Dose	To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Clearance Rate for Participants Who Received a Single Dose	To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Vd for Participants Who Received a Single Dose	To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
ke for Participants Who Received a Single Dose	To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.	blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
AUCss for Participants Who Received Multiple Dose	To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.	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.
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose	To calculate Css_min,Css_max and Css_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.	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.
Tmax,t1/2 for Participants Who Received Multiple Dose	To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.	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.
CL for Participants Who Received Multiple Dose	To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.	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.
Fluctuation Index (DF) for Participants Who Received Multiple Dose	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.	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.
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.	Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.	post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)	Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.	post dose 24h
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)	The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.	Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)	Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .	post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: OXYC09-CN-102