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CompletedNCT01643772Updated Oct 21, 2019Results posted

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

A Phase 1 interventional study of Oxycodone hydrochloride in Pain, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Completed at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd (part of Mundipharma) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pain

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 61 is close to the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Browse Mundipharma (China) Pharmaceutical Co. Ltd studies →All Mundipharma studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 range ≥19, \<24;
  • score ≥ 70;
  • The results of liver function and kidney tests must meet the following criteria: 、AST is within the 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 examination results are normal;
  • Patients must have given a written prior to this trial, and have the capability to complete every required test.

Exclusion criteria

Exclusion Criteria:

  • Have 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- 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Oxycodone Hydrochloride 5 mg Capsules

    Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting

    Drug: Oxycodone hydrochloride

  • Experimental
    Oxycodone Hydrochloride 10 mg Capsules

    Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting

    Drug: Oxycodone hydrochloride

  • Experimental
    Oxycodone Hydrochloride 20 mg Capsules

    Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting

    Drug: Oxycodone hydrochloride

  • 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

Interventions

  • DrugOxycodone 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.

    Also known as: OxyNorm® Capsules

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  2. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  3. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  4. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  5. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  6. 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.

    Time frame: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

  7. AUCss for Participants Who Received Multiple Dose

    To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

    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.

  8. 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.

    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.

  9. 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.

    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.

  10. 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.

    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.

  11. 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.

    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.

  12. 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.

    Time frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

  13. 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.

    Time frame: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

  14. 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.

    Time frame: post dose 24h

  15. 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.

    Time frame: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

  16. 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 .

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

07

Results

Posted Oct 21, 2019

Participant flow

The study was conducted in phase I unit in two public hospitals, the first subject took the first dose study medication on 13May2011, the last subject took the last dose on 6Jul2012.

Participant flow — Overall Study
MilestoneOxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose
Started15151516
Completed15151514
Not completed0002
Withdrew: Protocol violation0001
Withdrew: Adverse event0001

Outcome measures

PrimaryAUC0-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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · ng*hr*ml
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
ng*hr*mlOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycondone(AUC0-t)57.03 ± 14.62102.10 ± 23.94205.89 ± 58.03
Oxycondone(AUC0-∞)58.38 ± 15.41104.56 ± 25.16210.61 ± 59.89
Noroxycodone(AUC0-t)38.85 ± 9.6189.76 ± 29.13163.68 ± 43.29
Noroxycodone(AUC0-∞)41.93 ± 11.0999.15 ± 34.11178.61 ± 46.70
Hydroxymorphine(AUC0-t)—3.12 ± 03.79 ± 0
Hydroxymorphine(AUC0-∞)0 ± 03.96 ± 04.36 ± 0
Normethoxymorphone(AUC0-t)13.27 ± 10.4328.69 ± 26.3937.64 ± 17.51
Normethoxymorphone(AUC0-∞)15.07 ± 11.5433.31 ± 29.2943.85 ± 19.42
PrimaryCmax,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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · ng*mL
Cmax,Clast for Participants Who Received a Single Dose
ng*mLOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycodone(Cmax)12.97 ± 2.6721.14 ± 4.5835.56 ± 14.18
Noroxycodone(Cmax)6.19 ± 2.1511.62 ± 2.7919.19 ± 5.88
Hydroxymorphine(Cmax)0.27 ± 0.120.42 ± 0.200.76 ± 0.29
Normethoxymorphone(Cmax)1.64 ± 1.521.77 ± 1.463.52 ± 1.75
Oxycodone(Clast)0.20 ± 0.110.37 ± 0.200.74 ± 0.30
Noroxycodone(Clast)0.32 ± 0.170.89 ± 0.511.56 ± 0.47
Hydroxymorphine(Clast)—0.05 ± 00.05 ± 0
Normethoxymorphone(Clast)0.16 ± 0.120.36 ± 0.280.49 ± 0.25
PrimaryTmax,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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · hour
Tmax,t1/2 for Participants Who Received a Single Dose
hourOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycodone (Tmax)0.98 ± 0.430.80 ± 0.220.73 ± 0.18
Oxycodone (t1/2)4.42 ± 0.704.38 ± 0.574.24 ± 0.52
Noroxycodone (Tmax)1.32 ± 1.361.08 ± 0.820.98 ± 0.64
Noroxycodone (t1/2)6.22 ± 1.186.63 ± 1.476.59 ± 0.61
Hydroxymorphine(Tmax)0.90 ± 0.320.87 ± 0.331.07 ± 0.94
Hydroxymorphine (t1/2)—11.70 ± 07.90 ± 0
Normethoxymorphone(Tmax)1.62 ± 1.381.77 ± 1.462.04 ± 1.84
Normethoxymorphone(t1/2)7.78 ± 1.719.17 ± 1.938.22 ± 2.28
PrimaryClearance 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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · L*hour
Clearance Rate for Participants Who Received a Single Dose
L*hourOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycodone (CL)91.49 ± 24.45101.53 ± 27.54101.33 ± 25.16
Noroxycodone (CL)125.78 ± 28.40113.30 ± 40.85119.38 ± 31.09
Hydroxymorphine(CL)—2525.30 ± 04587.50 ± 0
Normethoxymorphone(CL)443.45 ± 192.68530.65 ± 368.02681.64 ± 736.51
PrimaryVd 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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · L
Vd for Participants Who Received a Single Dose
LOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycodone568.11 ± 118.51626.45 ± 115.70611.17 ± 137.94
Noroxycodone1119.22 ± 312.371026.65 ± 230.161138.72 ± 335.51
Hydroxymorphine—42608.80 ± 052264.20 ± 0
Normethoxymorphone5004.50 ± 2443.167297.56 ± 5341.917460.04 ± 5956.86
Primaryke 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.

Time frame:
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Reported as:
Mean · h^-1
ke for Participants Who Received a Single Dose
h^-1Oxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycodone0.16 ± 0.030.16 ± 0.020.17 ± 0.02
Noroxycodone0.12 ± 0.020.11 ± 0.020.11 ± 0.01
Hydroxymorphine—0.06 ± 00.09 ± 0
Normethoxymorphone0.09 ± 0.020.08 ± 0.020.10 ± 0.05
PrimaryAUCss for Participants Who Received Multiple Dose

To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.

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.
Reported as:
Mean · ng*hours*mL
AUCss for Participants Who Received Multiple Dose
ng*hours*mLOxycodone Hydrochloride Multiple Dose
Oxycodone156.03 ± 72.07
Noroxycodone122.69 ± 39.02
Hydroxymorphine4.51 ± 1.40
Normethoxymorphone16.56 ± 8.34
PrimaryCss_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.

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.
Reported as:
Mean · ng/ml
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
ng/mlOxycodone Hydrochloride Multiple Dose
Oxycodone(Css_min)16.92 ± 8.71
Noroxycodone(Css_min)15.74 ± 5.58
Hydroxymorphine(Css_min)0.40 ± 0.20
Normethoxymorphone(Css_min)2.18 ± 1.02
Oxycodone(Css_max )40.17 ± 15.38
Noroxycodone(Css_max )26.71 ± 8.03
Hydroxymorphine(Css_max )1.10 ± 0.47
Normethoxymorphone(Css_max )3.65 ± 1.97
Oxycodone(Css_av)26.01 ± 12.01
Noroxycodone(Css_av)20.44 ± 6.50
Hydroxymorphine(Css_av)0.75 ± 0.24
Normethoxymorphone(Css_av)2.76 ± 1.39
PrimaryTmax,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.

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.
Reported as:
Mean · hour
Tmax,t1/2 for Participants Who Received Multiple Dose
hourOxycodone Hydrochloride Multiple Dose
Oxycodone( Tmax)1.35 ± 0.65
Noroxycodone( Tmax)1.51 ± 1.00
Hydroxymorphine( Tmax)1.49 ± 1.00
Normethoxymorphone( Tmax)1.86 ± 1.48
Oxycodone(t1/2)5.07 ± 1.47
Noroxycodone(t1/2)7.23 ± 1.92
Hydroxymorphine(t1/2)8.09 ± 2.60
Normethoxymorphone(t1/2)9.07 ± 1.96
PrimaryCL 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.

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.
Reported as:
Mean · L*hour
CL for Participants Who Received Multiple Dose
L*hourOxycodone Hydrochloride Multiple Dose
Oxycodone73.54 ± 24.08
Noroxycodone90.66 ± 32.56
Hydroxymorphine2374.20 ± 597.75
Normethoxymorphone773.01 ± 431.19
PrimaryFluctuation 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.

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.
Reported as:
Mean · ng/ml
Fluctuation Index (DF) for Participants Who Received Multiple Dose
ng/mlOxycodone Hydrochloride Multiple Dose
Oxycodone94.11 ± 32.64
Noroxycodone55.75 ± 23.54
Hydroxymorphine123.95 ± 57.22
Normethoxymorphone52.07 ± 37.68
PrimaryThe 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.

Time frame:
Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Reported as:
Mean · μg
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
μgOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycondone(Pre-dose)0.00 ± 0.000.00 ± 0.000.00 ± 0.00
Oxycondone(post dose0-2h)25.69 ± 29.5554.55 ± 79.39108.57 ± 171.53
Oxycondone(post dose2-4h)64.24 ± 72.40172.38 ± 192.35316.07 ± 188.88
Oxycondone(post dose4-8h)64.93 ± 56.60169.28 ± 268.13165.45 ± 101.00
Oxycondone(post dose8-12h)56.07 ± 84.8178.48 ± 91.9171.07 ± 76.02
Oxycondone(post dose12-24h)40.30 ± 88.5836.12 ± 33.6667.92 ± 86.71
Noroxycodone(Pre-dose)0 ± 00 ± 00 ± 0
Noroxycodone(post dose0-2h)23.29 ± 39.9463.80 ± 83.33157.75 ± 229.32
Noroxycodone(post dose2-4h)105.53 ± 112.06346.22 ± 262.65784.70 ± 390.56
Noroxycodone(post dose4-8h)153.49 ± 124.65418.95 ± 527.24712.81 ± 417.09
Noroxycodone(post dose8-12h)139.45 ± 138.45212.68 ± 170.80360.37 ± 375.81
Noroxycodone(post dose12-24h)53.09 ± 41.21128.75 ± 90.37265.31 ± 400.05
Hydroxymorphine(Pre-dose)0 ± 00 ± 00 ± 0
Hydroxymorphine(post dose0-2h)0.51 ± 0.650.94 ± 1.412.89 ± 4.87
Hydroxymorphine(post dose2-4h)1.03 ± 1.032.52 ± 3.029.99 ± 7.14
Hydroxymorphine(post dose4-8h)1.72 ± 1.465.80 ± 12.625.85 ± 6.09
Hydroxymorphine(post dose8-12h)2.07 ± 3.392.97 ± 4.022.49 ± 2.62
Hydroxymorphine(post dose12-24h)2.31 ± 6.151.67 ± 1.862.90 ± 3.74
Normethoxymorphone(Pre-dose)0 ± 00 ± 00 ± 0
Normethoxymorphone(post dose0-2h)3.97 ± 6.967.16 ± 11.488.53 ± 13.63
Normethoxymorphone(post dose2-4h)15.44 ± 12.7823.53 ± 16.8640.29 ± 33.67
Normethoxymorphone(post dose4-8h)25.15 ± 33.8268.87 ± 131.2439.64 ± 23.90
Normethoxymorphone(post dose8-12h)28.59 ± 30.0030.17 ± 21.6248.38 ± 49.36
Normethoxymorphone(post dose12-24h)26.74 ± 30.3330.16 ± 34.2833.76 ± 31.67
PrimaryCumulative 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.

Time frame:
post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Reported as:
Mean · μg
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
μgOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycondone(post dose0-2h)25.69 ± 29.5554.55 ± 79.39108.57 ± 171.53
Oxycondone(post dose2-4h)89.93 ± 91.36226.92 ± 244.12424.64 ± 326.09
Oxycondone(post dose4-8h)154.86 ± 129.52396.20 ± 410.41590.08 ± 361.27
Oxycondone(post dose8-12h)210.92 ± 203.25474.68 ± 455.83661.15 ± 338.34
Oxycondone(post dose12-24h)251.22 ± 198.78510.80 ± 462.41729.07 ± 343.84
Noroxycodone(post dose0-2h)23.29 ± 39.9463.80 ± 83.33157.75 ± 229.32
Noroxycodone(post dose2-4h)128.82 ± 117.04410.02 ± 283.62942.44 ± 529.85
Noroxycodone(post dose4-8h)282.31 ± 192.38828.97 ± 629.001655.25 ± 736.42
Noroxycodone(post dose8-12h)421.75 ± 222.631041.66 ± 699.412015.62 ± 865.69
Noroxycodone(post dose12-24h)474.85 ± 232.061170.41 ± 703.512280.92 ± 936.47
Hydroxymorphine(post dose0-2h)0.51 ± 0.650.94 ± 1.412.89 ± 4.87
Hydroxymorphine(post dose2-4h)1.54 ± 1.563.46 ± 3.7912.88 ± 10.40
Hydroxymorphine(post dose4-8h)3.27 ± 2.479.27 ± 13.8918.73 ± 15.23
Hydroxymorphine(post dose8-12h)5.33 ± 4.8312.24 ± 16.3321.22 ± 15.56
Hydroxymorphine(post dose12-24h)7.64 ± 6.8113.91 ± 17.1324.11 ± 15.73
Normethoxymorphone(post dose0-2h)3.97 ± 6.967.16 ± 11.488.53 ± 13.63
Normethoxymorphone(post dose2-4h)19.40 ± 18.4530.68 ± 19.1548.82 ± 40.37
Normethoxymorphone(post dose4-8h)44.55 ± 44.6299.55 ± 143.1588.46 ± 53.96
Normethoxymorphone(post dose8-12h)73.14 ± 58.19129.72 ± 154.63136.84 ± 65.32
Normethoxymorphone(post dose12-24h)99.87 ± 76.02159.88 ± 184.11170.60 ± 74.03
PrimaryAverage 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.

Time frame:
post dose 24h
Reported as:
Mean · % of ug
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
% of ugOxycodone Hydrochloride Single Dose 5 mgOxycodone Hydrochloride Single Dose 10 mgOxycodone Hydrochloride Single Dose 20 mg
Oxycondone5.02 ± 3.985.11 ± 4.623.65 ± 1.72
Noroxycodone9.50 ± 4.6411.70 ± 7.0411.40 ± 4.68
Hydroxymorphine0.15 ± 0.140.14 ± 0.170.12 ± 0.08
Normethoxymorphone2.00 ± 1.521.60 ± 1.840.85 ± 0.37
PrimaryThe 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.

Time frame:
Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day
Reported as:
Mean · μg
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
μgOxycodone Hydrochloride Multiple Dose 10 mg
Oxycondone(Pre-dose)745.99 ± 1106.32
Oxycondone(post dose0-2h)263.32 ± 236.25
Oxycondone(post dose2-4h)342.64 ± 301.21
Oxycondone(post dose4-8h)431.70 ± 532.48
Oxycondone(post dose8-12h)137.13 ± 107.95
Oxycondone(post dose12-24h)344.15 ± 516.94
Noroxycodone(Pre-dose)897.44 ± 1121.80
Noroxycodone(post dose0-2h)372.51 ± 290.26
Noroxycodone(post dose2-4h)438.24 ± 218.90
Noroxycodone(post dose4-8h)515.39 ± 423.80
Noroxycodone(post dose8-12h)500.42 ± 717.43
Noroxycodone(post dose12-24h)865.37 ± 861.94
Hydroxymorphine(Pre-dose)9.43 ± 10.39
Hydroxymorphine(post dose0-2h)6.13 ± 8.11
Hydroxymorphine(post dose2-4h)24.03 ± 59.61
Hydroxymorphine(post dose4-8h)24.52 ± 27.45
Hydroxymorphine(post dose8-12h)15.10 ± 17.60
Hydroxymorphine(post dose12-24h)31.73 ± 36.65
Normethoxymorphone(Pre-dose)337.01 ± 460.24
Normethoxymorphone(post dose0-2h)130.63 ± 100.61
Normethoxymorphone(post dose2-4h)208.27 ± 183.64
Normethoxymorphone(post dose4-8h)262.56 ± 382.79
Normethoxymorphone(post dose8-12h)102.36 ± 91.74
Normethoxymorphone(post dose12-24h)240.75 ± 332.72
PrimaryCumulative 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 .

Time frame:
post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day
Reported as:
Mean · μg
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
μgOxycodone Hydrochloride Single Dose 10 mg
Oxycondone(post dose0-2h)263.32 ± 236.25
Oxycondone(post dose2-4h)605.96 ± 479.83
Oxycondone(post dose4-8h)1037.66 ± 985.45
Oxycondone(post dose8-12h)913.59 ± 374.77
Oxycondone(post dose12-24h)1290.63 ± 720.65
Noroxycodone(post dose0-2h)372.51 ± 290.26
Noroxycodone(post dose2-4h)810.75 ± 419.08
Noroxycodone(post dose4-8h)1326.14 ± 645.18
Noroxycodone(post dose8-12h)1693.83 ± 978.49
Noroxycodone(post dose12-24h)2618.44 ± 1237.37
Hydroxymorphine(post dose0-2h)6.13 ± 8.11
Hydroxymorphine(post dose2-4h)30.16 ± 64.24
Hydroxymorphine(post dose4-8h)54.68 ± 67.67
Hydroxymorphine(post dose8-12h)72.85 ± 72.84
Hydroxymorphine(post dose12-24h)108.81 ± 77.11
Normethoxymorphone(post dose0-2h)130.63 ± 100.61
Normethoxymorphone(post dose2-4h)338.90 ± 241.50
Normethoxymorphone(post dose4-8h)601.46 ± 566.37
Normethoxymorphone(post dose8-12h)575.47 ± 287.77
Normethoxymorphone(post dose12-24h)796.81 ± 518.90

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxycodone Hydrochloride Single Dose(5mg)0/15 (0%)0/15 (0%)8/15 (53.3%)
Oxycodone Hydrochloride Single Dose(10mg)0/15 (0%)0/15 (0%)11/15 (73.3%)
Oxycodone Hydrochloride Single Dose(20mg)0/15 (0%)0/15 (0%)14/15 (93.3%)
Oxycodone Hydrochloride Multiple Dose(10mg)0/16 (0%)0/16 (0%)12/16 (75%)
Most frequent other events
Most frequent other events
EventOxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose(10mg)
DizzinessNervous system disorders4/1510/1514/154/16
NauseaGastrointestinal disorders2/155/1510/154/16
VomitingGastrointestinal disorders2/153/157/156/16
DrowsinessNervous system disorders4/153/155/150/16

Baseline characteristics

PP Population

Age, Continuous
Age, Continuous(year)Oxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose(10mg)Total
Mean40.22 ± 4.9039.63 ± 6.2136.16 ± 8.6848.62 ± 7.8741.11 ± 8.14
Sex: Female, Male
Sex: Female, Male(Participants)Oxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose(10mg)Total
Female885728
Male779730
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Oxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose(10mg)Total
American Indian or Alaska Native00000
Asian1515141458
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White00000
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Oxycodone Hydrochloride Single Dose(5mg)Oxycodone Hydrochloride Single Dose(10mg)Oxycodone Hydrochloride Single Dose(20mg)Oxycodone Hydrochloride Multiple Dose(10mg)Total
China1515141461
08

Study locations

1 site
  • Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army
    Beijing, China
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2019, 7 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2011
First posted
Jul 18, 2012
Start
May 2011
Primary completionActual
Jul 2012
CompletionActual
Jul 2012
Results first posted
Oct 21, 2019
Last update
Oct 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01643772
Lead sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
May 2011
Primary completion
Jul 2012
Completion
Jul 2012
Results posted
Oct 21, 2019
Last update
Oct 21, 2019

Study contacts

Mundipharma China Ltd.
study chair · Mundipharma China Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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