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

Pain Clinical Trial

Official title:

OxyNorm® Capsules (Immediate-Release) PK Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643772
• Other study ID #: OXYC09-CN-102
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2019
• Source: Mundipharma (China) Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma (China) Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t and AUC0-8 for Participants Who Received a Single Dose	To calculate AUC0-t AUC0-8of 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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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