PainPhase 1NCT01643772

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

A Phase 1 study testing Oxycodone hydrochloride in people with Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Pain
What is being tested?: Oxycodone hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteChina
Study dates: May 2011to Jul 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: OxyNorm® Capsules (Immediate-Release) PK Study

Read the 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.

Conditions: Pain
Being tested: Oxycodone hydrochloride
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone hydrochlorideDrug
Also called OxyNorm® Capsules
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.

Study groups in NCT01643772
Study group	Role	What they receive
Oxycodone Hydrochloride 5 mg Capsules	Experimental	Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting Receives: Drug: Oxycodone hydrochloride
Oxycodone Hydrochloride 10 mg Capsules	Experimental	Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting Receives: Drug: Oxycodone hydrochloride
Oxycodone Hydrochloride 20 mg Capsules	Experimental	Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting Receives: Drug: Oxycodone hydrochloride
Oxycodone Hydrochloride 10 mg Capsules(multi-dose)	Experimental	Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning Receives: Drug: Oxycodone hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jul 2012

First posted18 Jul 2012 (estimated)
Study startMay 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01643772
Sponsor's protocol ID: OXYC09-CN-102
Status last verified: Sep 2019
First submitted: 17 Nov 2011
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OxyNorm® Capsules (Immediate-Release) PK Study
ClinicalTrials.gov ID: NCT01643772
Acronym / sponsor ID: OXYC09-CN-102
Conditions: Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 18 Jul 2012 (estimated)
Results: Posted 21 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Oxycodone Hydrochloride 5 mg Capsules	Experimental	Drug: Oxycodone hydrochlorideGroup 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Oxycodone Hydrochloride 10 mg Capsules	Experimental	Drug: Oxycodone hydrochlorideGroup 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Oxycodone Hydrochloride 20 mg Capsules	Experimental	Drug: Oxycodone hydrochlorideGroup 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Oxycodone Hydrochloride 10 mg Capsules(multi-dose)	Experimental	Drug: Oxycodone hydrochlorideGroup 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone hydrochlorideAlso: OxyNorm® CapsulesThe 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.	Drug	Oxycodone Hydrochloride 10 mg Capsules, Oxycodone Hydrochloride 10 mg Capsules(multi-dose), Oxycodone Hydrochloride 20 mg Capsules, Oxycodone Hydrochloride 5 mg Capsules

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 .

Results and safety

Results posted to the registry on 21 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodone Hydrochloride Single Dose(5mg)	15	15
Oxycodone Hydrochloride Single Dose(10mg)	15	15
Oxycodone Hydrochloride Single Dose(20mg)	15	15
Oxycodone Hydrochloride Multiple Dose	16	14

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*hr*ml

Measure	Oxycodone Hydrochloride Single Dose 5 mg n = 15	Oxycodone Hydrochloride Single Dose 10 mg n = 15	Oxycodone Hydrochloride Single Dose 20 mg n = 14
Oxycondone(AUC0-t)	57.03 (14.62)	102.10 (23.94)	205.89 (58.03)
Oxycondone(AUC0-∞)	58.38 (15.41)	104.56 (25.16)	210.61 (59.89)
Noroxycodone(AUC0-t)	38.85 (9.61)	89.76 (29.13)	163.68 (43.29)
Noroxycodone(AUC0-∞)	41.93 (11.09)	99.15 (34.11)	178.61 (46.70)
Hydroxymorphine(AUC0-t)	–	3.12 (0)	3.79 (0)
Hydroxymorphine(AUC0-∞)	0 (0)	3.96 (0)	4.36 (0)
Normethoxymorphone(AUC0-t)	13.27 (10.43)	28.69 (26.39)	37.64 (17.51)
Normethoxymorphone(AUC0-∞)	15.07 (11.54)	33.31 (29.29)	43.85 (19.42)

Population analysed: PP Population

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*mL

Measure	Oxycodone Hydrochloride Single Dose 5 mg n = 15	Oxycodone Hydrochloride Single Dose 10 mg n = 15	Oxycodone Hydrochloride Single Dose 20 mg n = 14
Oxycodone(Cmax)	12.97 (2.67)	21.14 (4.58)	35.56 (14.18)
Noroxycodone(Cmax)	6.19 (2.15)	11.62 (2.79)	19.19 (5.88)
Hydroxymorphine(Cmax)	0.27 (0.12)	0.42 (0.20)	0.76 (0.29)
Normethoxymorphone(Cmax)	1.64 (1.52)	1.77 (1.46)	3.52 (1.75)
Oxycodone(Clast)	0.20 (0.11)	0.37 (0.20)	0.74 (0.30)
Noroxycodone(Clast)	0.32 (0.17)	0.89 (0.51)	1.56 (0.47)
Hydroxymorphine(Clast)	–	0.05 (0)	0.05 (0)
Normethoxymorphone(Clast)	0.16 (0.12)	0.36 (0.28)	0.49 (0.25)

Population analysed: PP population

Primary outcome: 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.. Mean (Standard Deviation). Unit: hour

Measure	Oxycodone Hydrochloride Single Dose 5 mg n = 15	Oxycodone Hydrochloride Single Dose 10 mg n = 15	Oxycodone Hydrochloride Single Dose 20 mg n = 14
Oxycodone (Tmax)	0.98 (0.43)	0.80 (0.22)	0.73 (0.18)
Oxycodone (t1/2)	4.42 (0.70)	4.38 (0.57)	4.24 (0.52)
Noroxycodone (Tmax)	1.32 (1.36)	1.08 (0.82)	0.98 (0.64)
Noroxycodone (t1/2)	6.22 (1.18)	6.63 (1.47)	6.59 (0.61)
Hydroxymorphine(Tmax)	0.90 (0.32)	0.87 (0.33)	1.07 (0.94)
Hydroxymorphine (t1/2)	–	11.70 (0)	7.90 (0)
Normethoxymorphone(Tmax)	1.62 (1.38)	1.77 (1.46)	2.04 (1.84)
Normethoxymorphone(t1/2)	7.78 (1.71)	9.17 (1.93)	8.22 (2.28)

Population analysed: PP popluation

Primary outcome: 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.. Mean (Standard Deviation). Unit: L*hour

Measure	Oxycodone Hydrochloride Single Dose 5 mg n = 15	Oxycodone Hydrochloride Single Dose 10 mg n = 15	Oxycodone Hydrochloride Single Dose 20 mg n = 14
Oxycodone (CL)	91.49 (24.45)	101.53 (27.54)	101.33 (25.16)
Noroxycodone (CL)	125.78 (28.40)	113.30 (40.85)	119.38 (31.09)
Hydroxymorphine(CL)	–	2525.30 (0)	4587.50 (0)
Normethoxymorphone(CL)	443.45 (192.68)	530.65 (368.02)	681.64 (736.51)

Population analysed: PP popuplation

Adverse events

Time frame: Single dose group the screening period is maximal 7 days, then 1 day dosing and sampling following by 1 day safety follow up, so total 9 days maximal. Multiple dose group the screening period is maximal 7 days, then 4 days dosing and sampleing following by 1 day safety follow up, so total 12 days maximal.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodone Hydrochloride Single Dose(5mg)	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Oxycodone Hydrochloride Single Dose(10mg)	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
Oxycodone Hydrochloride Single Dose(20mg)	0 of 15 (0%)	14 of 15 (93.3%)	0 of 15
Oxycodone Hydrochloride Multiple Dose(10mg)	0 of 16 (0%)	12 of 16 (75%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mundipharma China Ltd. study chair

Mundipharma China Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxycodone hydrochloride in people with Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01643772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.