Trial Outcomes & Findings for OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study (NCT NCT01643772)
NCT ID: NCT01643772
Last Updated: 2019-10-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Results posted on
2019-10-21
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.
The study has a 7-days screening phase, for the subject who meet all the inclusion and exclusion criteria was dosed without run-in or wash out period.
Participant milestones
| Measure |
Oxycodone Hydrochloride Single Dose(5mg)
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(10mg)
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(20mg)
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Multiple Dose
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Oxycodone Hydrochloride Single Dose(5mg)
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(10mg)
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(20mg)
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Multiple Dose
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PP population
Baseline characteristics by cohort
| Measure |
Oxycodone Hydrochloride Single Dose(5mg)
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(10mg)
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(20mg)
n=15 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Multiple Dose(10mg)
n=16 Participants
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.22 year
STANDARD_DEVIATION 4.90 • n=15 Participants • PP population
|
39.63 year
STANDARD_DEVIATION 6.21 • n=15 Participants • PP population
|
36.16 year
STANDARD_DEVIATION 8.68 • n=14 Participants • PP population
|
48.62 year
STANDARD_DEVIATION 7.87 • n=14 Participants • PP population
|
41.11 year
STANDARD_DEVIATION 8.14 • n=58 Participants • PP population
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants • PP Population
|
8 Participants
n=15 Participants • PP Population
|
5 Participants
n=14 Participants • PP Population
|
7 Participants
n=14 Participants • PP Population
|
28 Participants
n=58 Participants • PP Population
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants • PP Population
|
7 Participants
n=15 Participants • PP Population
|
9 Participants
n=14 Participants • PP Population
|
7 Participants
n=14 Participants • PP Population
|
30 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=15 Participants • PP Population
|
15 Participants
n=15 Participants • PP Population
|
14 Participants
n=14 Participants • PP Population
|
14 Participants
n=14 Participants • PP Population
|
58 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=15 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=14 Participants • PP Population
|
0 Participants
n=58 Participants • PP Population
|
|
Region of Enrollment
China
|
15 participants
n=15 Participants • PP Population
|
15 participants
n=15 Participants • PP Population
|
14 participants
n=14 Participants • PP Population
|
14 participants
n=14 Participants • PP Population
|
61 participants
n=58 Participants • PP Population
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP Population
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.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Oxycondone(AUC0-t)
|
57.03 ng*hr*ml
Standard Deviation 14.62
|
102.10 ng*hr*ml
Standard Deviation 23.94
|
205.89 ng*hr*ml
Standard Deviation 58.03
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Oxycondone(AUC0-∞)
|
58.38 ng*hr*ml
Standard Deviation 15.41
|
104.56 ng*hr*ml
Standard Deviation 25.16
|
210.61 ng*hr*ml
Standard Deviation 59.89
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Noroxycodone(AUC0-t)
|
38.85 ng*hr*ml
Standard Deviation 9.61
|
89.76 ng*hr*ml
Standard Deviation 29.13
|
163.68 ng*hr*ml
Standard Deviation 43.29
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Noroxycodone(AUC0-∞)
|
41.93 ng*hr*ml
Standard Deviation 11.09
|
99.15 ng*hr*ml
Standard Deviation 34.11
|
178.61 ng*hr*ml
Standard Deviation 46.70
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Hydroxymorphine(AUC0-t)
|
—
|
3.12 ng*hr*ml
Standard Deviation 0
|
3.79 ng*hr*ml
Standard Deviation 0
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Hydroxymorphine(AUC0-∞)
|
0 ng*hr*ml
Standard Deviation 0
|
3.96 ng*hr*ml
Standard Deviation 0
|
4.36 ng*hr*ml
Standard Deviation 0
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Normethoxymorphone(AUC0-t)
|
13.27 ng*hr*ml
Standard Deviation 10.43
|
28.69 ng*hr*ml
Standard Deviation 26.39
|
37.64 ng*hr*ml
Standard Deviation 17.51
|
|
AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Normethoxymorphone(AUC0-∞)
|
15.07 ng*hr*ml
Standard Deviation 11.54
|
33.31 ng*hr*ml
Standard Deviation 29.29
|
43.85 ng*hr*ml
Standard Deviation 19.42
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP population
To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Cmax,Clast for Participants Who Received a Single Dose
Oxycodone(Cmax)
|
12.97 ng*mL
Standard Deviation 2.67
|
21.14 ng*mL
Standard Deviation 4.58
|
35.56 ng*mL
Standard Deviation 14.18
|
|
Cmax,Clast for Participants Who Received a Single Dose
Noroxycodone(Cmax)
|
6.19 ng*mL
Standard Deviation 2.15
|
11.62 ng*mL
Standard Deviation 2.79
|
19.19 ng*mL
Standard Deviation 5.88
|
|
Cmax,Clast for Participants Who Received a Single Dose
Hydroxymorphine(Cmax)
|
0.27 ng*mL
Standard Deviation 0.12
|
0.42 ng*mL
Standard Deviation 0.20
|
0.76 ng*mL
Standard Deviation 0.29
|
|
Cmax,Clast for Participants Who Received a Single Dose
Normethoxymorphone(Cmax)
|
1.64 ng*mL
Standard Deviation 1.52
|
1.77 ng*mL
Standard Deviation 1.46
|
3.52 ng*mL
Standard Deviation 1.75
|
|
Cmax,Clast for Participants Who Received a Single Dose
Oxycodone(Clast)
|
0.20 ng*mL
Standard Deviation 0.11
|
0.37 ng*mL
Standard Deviation 0.20
|
0.74 ng*mL
Standard Deviation 0.30
|
|
Cmax,Clast for Participants Who Received a Single Dose
Noroxycodone(Clast)
|
0.32 ng*mL
Standard Deviation 0.17
|
0.89 ng*mL
Standard Deviation 0.51
|
1.56 ng*mL
Standard Deviation 0.47
|
|
Cmax,Clast for Participants Who Received a Single Dose
Hydroxymorphine(Clast)
|
—
|
0.05 ng*mL
Standard Deviation 0
|
0.05 ng*mL
Standard Deviation 0
|
|
Cmax,Clast for Participants Who Received a Single Dose
Normethoxymorphone(Clast)
|
0.16 ng*mL
Standard Deviation 0.12
|
0.36 ng*mL
Standard Deviation 0.28
|
0.49 ng*mL
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP popluation
To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Oxycodone (Tmax)
|
0.98 hour
Standard Deviation 0.43
|
0.80 hour
Standard Deviation 0.22
|
0.73 hour
Standard Deviation 0.18
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Oxycodone (t1/2)
|
4.42 hour
Standard Deviation 0.70
|
4.38 hour
Standard Deviation 0.57
|
4.24 hour
Standard Deviation 0.52
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Noroxycodone (Tmax)
|
1.32 hour
Standard Deviation 1.36
|
1.08 hour
Standard Deviation 0.82
|
0.98 hour
Standard Deviation 0.64
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Noroxycodone (t1/2)
|
6.22 hour
Standard Deviation 1.18
|
6.63 hour
Standard Deviation 1.47
|
6.59 hour
Standard Deviation 0.61
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Hydroxymorphine(Tmax)
|
0.90 hour
Standard Deviation 0.32
|
0.87 hour
Standard Deviation 0.33
|
1.07 hour
Standard Deviation 0.94
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Hydroxymorphine (t1/2)
|
—
|
11.70 hour
Standard Deviation 0
|
7.90 hour
Standard Deviation 0
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Normethoxymorphone(Tmax)
|
1.62 hour
Standard Deviation 1.38
|
1.77 hour
Standard Deviation 1.46
|
2.04 hour
Standard Deviation 1.84
|
|
Tmax,t1/2 for Participants Who Received a Single Dose
Normethoxymorphone(t1/2)
|
7.78 hour
Standard Deviation 1.71
|
9.17 hour
Standard Deviation 1.93
|
8.22 hour
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP popuplation
To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Clearance Rate for Participants Who Received a Single Dose
Oxycodone (CL)
|
91.49 L*hour
Standard Deviation 24.45
|
101.53 L*hour
Standard Deviation 27.54
|
101.33 L*hour
Standard Deviation 25.16
|
|
Clearance Rate for Participants Who Received a Single Dose
Noroxycodone (CL)
|
125.78 L*hour
Standard Deviation 28.40
|
113.30 L*hour
Standard Deviation 40.85
|
119.38 L*hour
Standard Deviation 31.09
|
|
Clearance Rate for Participants Who Received a Single Dose
Hydroxymorphine(CL)
|
—
|
2525.30 L*hour
Standard Deviation 0
|
4587.50 L*hour
Standard Deviation 0
|
|
Clearance Rate for Participants Who Received a Single Dose
Normethoxymorphone(CL)
|
443.45 L*hour
Standard Deviation 192.68
|
530.65 L*hour
Standard Deviation 368.02
|
681.64 L*hour
Standard Deviation 736.51
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP population
To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Vd for Participants Who Received a Single Dose
Oxycodone
|
568.11 L
Standard Deviation 118.51
|
626.45 L
Standard Deviation 115.70
|
611.17 L
Standard Deviation 137.94
|
|
Vd for Participants Who Received a Single Dose
Noroxycodone
|
1119.22 L
Standard Deviation 312.37
|
1026.65 L
Standard Deviation 230.16
|
1138.72 L
Standard Deviation 335.51
|
|
Vd for Participants Who Received a Single Dose
Hydroxymorphine
|
—
|
42608.80 L
Standard Deviation 0
|
52264.20 L
Standard Deviation 0
|
|
Vd for Participants Who Received a Single Dose
Normethoxymorphone
|
5004.50 L
Standard Deviation 2443.16
|
7297.56 L
Standard Deviation 5341.91
|
7460.04 L
Standard Deviation 5956.86
|
PRIMARY outcome
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.Population: PP population
To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
ke for Participants Who Received a Single Dose
Oxycodone
|
0.16 h^-1
Standard Deviation 0.03
|
0.16 h^-1
Standard Deviation 0.02
|
0.17 h^-1
Standard Deviation 0.02
|
|
ke for Participants Who Received a Single Dose
Noroxycodone
|
0.12 h^-1
Standard Deviation 0.02
|
0.11 h^-1
Standard Deviation 0.02
|
0.11 h^-1
Standard Deviation 0.01
|
|
ke for Participants Who Received a Single Dose
Hydroxymorphine
|
—
|
0.06 h^-1
Standard Deviation 0
|
0.09 h^-1
Standard Deviation 0
|
|
ke for Participants Who Received a Single Dose
Normethoxymorphone
|
0.09 h^-1
Standard Deviation 0.02
|
0.08 h^-1
Standard Deviation 0.02
|
0.10 h^-1
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: 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.Population: PP population
To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
AUCss for Participants Who Received Multiple Dose
Oxycodone
|
156.03 ng*hours*mL
Standard Deviation 72.07
|
—
|
—
|
|
AUCss for Participants Who Received Multiple Dose
Noroxycodone
|
122.69 ng*hours*mL
Standard Deviation 39.02
|
—
|
—
|
|
AUCss for Participants Who Received Multiple Dose
Hydroxymorphine
|
4.51 ng*hours*mL
Standard Deviation 1.40
|
—
|
—
|
|
AUCss for Participants Who Received Multiple Dose
Normethoxymorphone
|
16.56 ng*hours*mL
Standard Deviation 8.34
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: multiple dose group has 14 subjects
To calculate Css\_min,Css\_max and Css\_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Oxycodone(Css_min)
|
16.92 ng/ml
Standard Deviation 8.71
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Noroxycodone(Css_min)
|
15.74 ng/ml
Standard Deviation 5.58
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Hydroxymorphine(Css_min)
|
0.40 ng/ml
Standard Deviation 0.20
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Normethoxymorphone(Css_min)
|
2.18 ng/ml
Standard Deviation 1.02
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Oxycodone(Css_max )
|
40.17 ng/ml
Standard Deviation 15.38
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Noroxycodone(Css_max )
|
26.71 ng/ml
Standard Deviation 8.03
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Hydroxymorphine(Css_max )
|
1.10 ng/ml
Standard Deviation 0.47
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Normethoxymorphone(Css_max )
|
3.65 ng/ml
Standard Deviation 1.97
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Oxycodone(Css_av)
|
26.01 ng/ml
Standard Deviation 12.01
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Noroxycodone(Css_av)
|
20.44 ng/ml
Standard Deviation 6.50
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Hydroxymorphine(Css_av)
|
0.75 ng/ml
Standard Deviation 0.24
|
—
|
—
|
|
Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Normethoxymorphone(Css_av)
|
2.76 ng/ml
Standard Deviation 1.39
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: multiple dose group has 14 subjects
To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Oxycodone( Tmax)
|
1.35 hour
Standard Deviation 0.65
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Noroxycodone( Tmax)
|
1.51 hour
Standard Deviation 1.00
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Hydroxymorphine( Tmax)
|
1.49 hour
Standard Deviation 1.00
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Normethoxymorphone( Tmax)
|
1.86 hour
Standard Deviation 1.48
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Oxycodone(t1/2)
|
5.07 hour
Standard Deviation 1.47
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Noroxycodone(t1/2)
|
7.23 hour
Standard Deviation 1.92
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Hydroxymorphine(t1/2)
|
8.09 hour
Standard Deviation 2.60
|
—
|
—
|
|
Tmax,t1/2 for Participants Who Received Multiple Dose
Normethoxymorphone(t1/2)
|
9.07 hour
Standard Deviation 1.96
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: multiple dose group has 14 subjects
To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
CL for Participants Who Received Multiple Dose
Oxycodone
|
73.54 L*hour
Standard Deviation 24.08
|
—
|
—
|
|
CL for Participants Who Received Multiple Dose
Noroxycodone
|
90.66 L*hour
Standard Deviation 32.56
|
—
|
—
|
|
CL for Participants Who Received Multiple Dose
Hydroxymorphine
|
2374.20 L*hour
Standard Deviation 597.75
|
—
|
—
|
|
CL for Participants Who Received Multiple Dose
Normethoxymorphone
|
773.01 L*hour
Standard Deviation 431.19
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: multiple dose group has 14 subjects
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.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Fluctuation Index (DF) for Participants Who Received Multiple Dose
Oxycodone
|
94.11 ng/ml
Standard Deviation 32.64
|
—
|
—
|
|
Fluctuation Index (DF) for Participants Who Received Multiple Dose
Noroxycodone
|
55.75 ng/ml
Standard Deviation 23.54
|
—
|
—
|
|
Fluctuation Index (DF) for Participants Who Received Multiple Dose
Hydroxymorphine
|
123.95 ng/ml
Standard Deviation 57.22
|
—
|
—
|
|
Fluctuation Index (DF) for Participants Who Received Multiple Dose
Normethoxymorphone
|
52.07 ng/ml
Standard Deviation 37.68
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24hThe excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose2-4h)
|
105.53 μg
Standard Deviation 112.06
|
346.22 μg
Standard Deviation 262.65
|
784.70 μg
Standard Deviation 390.56
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose4-8h)
|
153.49 μg
Standard Deviation 124.65
|
418.95 μg
Standard Deviation 527.24
|
712.81 μg
Standard Deviation 417.09
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose12-24h)
|
53.09 μg
Standard Deviation 41.21
|
128.75 μg
Standard Deviation 90.37
|
265.31 μg
Standard Deviation 400.05
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(Pre-dose)
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose12-24h)
|
2.31 μg
Standard Deviation 6.15
|
1.67 μg
Standard Deviation 1.86
|
2.90 μg
Standard Deviation 3.74
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(Pre-dose)
|
0.00 μg
Standard Deviation 0.00
|
0.00 μg
Standard Deviation 0.00
|
0.00 μg
Standard Deviation 0.00
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose0-2h)
|
25.69 μg
Standard Deviation 29.55
|
54.55 μg
Standard Deviation 79.39
|
108.57 μg
Standard Deviation 171.53
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose2-4h)
|
64.24 μg
Standard Deviation 72.40
|
172.38 μg
Standard Deviation 192.35
|
316.07 μg
Standard Deviation 188.88
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose4-8h)
|
64.93 μg
Standard Deviation 56.60
|
169.28 μg
Standard Deviation 268.13
|
165.45 μg
Standard Deviation 101.00
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose8-12h)
|
56.07 μg
Standard Deviation 84.81
|
78.48 μg
Standard Deviation 91.91
|
71.07 μg
Standard Deviation 76.02
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose12-24h)
|
40.30 μg
Standard Deviation 88.58
|
36.12 μg
Standard Deviation 33.66
|
67.92 μg
Standard Deviation 86.71
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(Pre-dose)
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose0-2h)
|
23.29 μg
Standard Deviation 39.94
|
63.80 μg
Standard Deviation 83.33
|
157.75 μg
Standard Deviation 229.32
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose8-12h)
|
139.45 μg
Standard Deviation 138.45
|
212.68 μg
Standard Deviation 170.80
|
360.37 μg
Standard Deviation 375.81
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose0-2h)
|
0.51 μg
Standard Deviation 0.65
|
0.94 μg
Standard Deviation 1.41
|
2.89 μg
Standard Deviation 4.87
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose2-4h)
|
1.03 μg
Standard Deviation 1.03
|
2.52 μg
Standard Deviation 3.02
|
9.99 μg
Standard Deviation 7.14
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose4-8h)
|
1.72 μg
Standard Deviation 1.46
|
5.80 μg
Standard Deviation 12.62
|
5.85 μg
Standard Deviation 6.09
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose8-12h)
|
2.07 μg
Standard Deviation 3.39
|
2.97 μg
Standard Deviation 4.02
|
2.49 μg
Standard Deviation 2.62
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(Pre-dose)
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
0 μg
Standard Deviation 0
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose0-2h)
|
3.97 μg
Standard Deviation 6.96
|
7.16 μg
Standard Deviation 11.48
|
8.53 μg
Standard Deviation 13.63
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose2-4h)
|
15.44 μg
Standard Deviation 12.78
|
23.53 μg
Standard Deviation 16.86
|
40.29 μg
Standard Deviation 33.67
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose4-8h)
|
25.15 μg
Standard Deviation 33.82
|
68.87 μg
Standard Deviation 131.24
|
39.64 μg
Standard Deviation 23.90
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose8-12h)
|
28.59 μg
Standard Deviation 30.00
|
30.17 μg
Standard Deviation 21.62
|
48.38 μg
Standard Deviation 49.36
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose12-24h)
|
26.74 μg
Standard Deviation 30.33
|
30.16 μg
Standard Deviation 34.28
|
33.76 μg
Standard Deviation 31.67
|
PRIMARY outcome
Timeframe: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24hCumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose0-2h)
|
25.69 μg
Standard Deviation 29.55
|
54.55 μg
Standard Deviation 79.39
|
108.57 μg
Standard Deviation 171.53
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose2-4h)
|
89.93 μg
Standard Deviation 91.36
|
226.92 μg
Standard Deviation 244.12
|
424.64 μg
Standard Deviation 326.09
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose4-8h)
|
154.86 μg
Standard Deviation 129.52
|
396.20 μg
Standard Deviation 410.41
|
590.08 μg
Standard Deviation 361.27
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose8-12h)
|
210.92 μg
Standard Deviation 203.25
|
474.68 μg
Standard Deviation 455.83
|
661.15 μg
Standard Deviation 338.34
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone(post dose12-24h)
|
251.22 μg
Standard Deviation 198.78
|
510.80 μg
Standard Deviation 462.41
|
729.07 μg
Standard Deviation 343.84
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose0-2h)
|
23.29 μg
Standard Deviation 39.94
|
63.80 μg
Standard Deviation 83.33
|
157.75 μg
Standard Deviation 229.32
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose2-4h)
|
128.82 μg
Standard Deviation 117.04
|
410.02 μg
Standard Deviation 283.62
|
942.44 μg
Standard Deviation 529.85
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose4-8h)
|
282.31 μg
Standard Deviation 192.38
|
828.97 μg
Standard Deviation 629.00
|
1655.25 μg
Standard Deviation 736.42
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose8-12h)
|
421.75 μg
Standard Deviation 222.63
|
1041.66 μg
Standard Deviation 699.41
|
2015.62 μg
Standard Deviation 865.69
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone(post dose12-24h)
|
474.85 μg
Standard Deviation 232.06
|
1170.41 μg
Standard Deviation 703.51
|
2280.92 μg
Standard Deviation 936.47
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose0-2h)
|
0.51 μg
Standard Deviation 0.65
|
0.94 μg
Standard Deviation 1.41
|
2.89 μg
Standard Deviation 4.87
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose2-4h)
|
1.54 μg
Standard Deviation 1.56
|
3.46 μg
Standard Deviation 3.79
|
12.88 μg
Standard Deviation 10.40
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose4-8h)
|
3.27 μg
Standard Deviation 2.47
|
9.27 μg
Standard Deviation 13.89
|
18.73 μg
Standard Deviation 15.23
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose8-12h)
|
5.33 μg
Standard Deviation 4.83
|
12.24 μg
Standard Deviation 16.33
|
21.22 μg
Standard Deviation 15.56
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine(post dose12-24h)
|
7.64 μg
Standard Deviation 6.81
|
13.91 μg
Standard Deviation 17.13
|
24.11 μg
Standard Deviation 15.73
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose0-2h)
|
3.97 μg
Standard Deviation 6.96
|
7.16 μg
Standard Deviation 11.48
|
8.53 μg
Standard Deviation 13.63
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose2-4h)
|
19.40 μg
Standard Deviation 18.45
|
30.68 μg
Standard Deviation 19.15
|
48.82 μg
Standard Deviation 40.37
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose4-8h)
|
44.55 μg
Standard Deviation 44.62
|
99.55 μg
Standard Deviation 143.15
|
88.46 μg
Standard Deviation 53.96
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose8-12h)
|
73.14 μg
Standard Deviation 58.19
|
129.72 μg
Standard Deviation 154.63
|
136.84 μg
Standard Deviation 65.32
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone(post dose12-24h)
|
99.87 μg
Standard Deviation 76.02
|
159.88 μg
Standard Deviation 184.11
|
170.60 μg
Standard Deviation 74.03
|
PRIMARY outcome
Timeframe: post dose 24hAverage cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=15 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
n=15 Participants
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
n=14 Participants
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Oxycondone
|
5.02 % of ug
Standard Deviation 3.98
|
5.11 % of ug
Standard Deviation 4.62
|
3.65 % of ug
Standard Deviation 1.72
|
|
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Noroxycodone
|
9.50 % of ug
Standard Deviation 4.64
|
11.70 % of ug
Standard Deviation 7.04
|
11.40 % of ug
Standard Deviation 4.68
|
|
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hydroxymorphine
|
0.15 % of ug
Standard Deviation 0.14
|
0.14 % of ug
Standard Deviation 0.17
|
0.12 % of ug
Standard Deviation 0.08
|
|
Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Normethoxymorphone
|
2.00 % of ug
Standard Deviation 1.52
|
1.60 % of ug
Standard Deviation 1.84
|
0.85 % of ug
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th dayThe excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(Pre-dose)
|
745.99 μg
Standard Deviation 1106.32
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(post dose0-2h)
|
263.32 μg
Standard Deviation 236.25
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(post dose2-4h)
|
342.64 μg
Standard Deviation 301.21
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(post dose4-8h)
|
431.70 μg
Standard Deviation 532.48
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(post dose8-12h)
|
137.13 μg
Standard Deviation 107.95
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Oxycondone(post dose12-24h)
|
344.15 μg
Standard Deviation 516.94
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(Pre-dose)
|
897.44 μg
Standard Deviation 1121.80
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(post dose0-2h)
|
372.51 μg
Standard Deviation 290.26
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(post dose2-4h)
|
438.24 μg
Standard Deviation 218.90
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(post dose4-8h)
|
515.39 μg
Standard Deviation 423.80
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(post dose8-12h)
|
500.42 μg
Standard Deviation 717.43
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Noroxycodone(post dose12-24h)
|
865.37 μg
Standard Deviation 861.94
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(Pre-dose)
|
9.43 μg
Standard Deviation 10.39
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(post dose0-2h)
|
6.13 μg
Standard Deviation 8.11
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(post dose2-4h)
|
24.03 μg
Standard Deviation 59.61
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(post dose4-8h)
|
24.52 μg
Standard Deviation 27.45
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(post dose8-12h)
|
15.10 μg
Standard Deviation 17.60
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hydroxymorphine(post dose12-24h)
|
31.73 μg
Standard Deviation 36.65
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(Pre-dose)
|
337.01 μg
Standard Deviation 460.24
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(post dose0-2h)
|
130.63 μg
Standard Deviation 100.61
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(post dose2-4h)
|
208.27 μg
Standard Deviation 183.64
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(post dose4-8h)
|
262.56 μg
Standard Deviation 382.79
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(post dose8-12h)
|
102.36 μg
Standard Deviation 91.74
|
—
|
—
|
|
The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Normethoxymorphone(post dose12-24h)
|
240.75 μg
Standard Deviation 332.72
|
—
|
—
|
PRIMARY outcome
Timeframe: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th dayCumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .
Outcome measures
| Measure |
Oxycodone Hydrochloride Single Dose 5 mg
n=14 Participants
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 10 mg
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose 20 mg
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
|---|---|---|---|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Normethoxymorphone(post dose4-8h)
|
601.46 μg
Standard Deviation 566.37
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Normethoxymorphone(post dose8-12h)
|
575.47 μg
Standard Deviation 287.77
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Oxycondone(post dose0-2h)
|
263.32 μg
Standard Deviation 236.25
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Oxycondone(post dose2-4h)
|
605.96 μg
Standard Deviation 479.83
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Oxycondone(post dose4-8h)
|
1037.66 μg
Standard Deviation 985.45
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Oxycondone(post dose8-12h)
|
913.59 μg
Standard Deviation 374.77
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Oxycondone(post dose12-24h)
|
1290.63 μg
Standard Deviation 720.65
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Noroxycodone(post dose0-2h)
|
372.51 μg
Standard Deviation 290.26
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Noroxycodone(post dose2-4h)
|
810.75 μg
Standard Deviation 419.08
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Noroxycodone(post dose4-8h)
|
1326.14 μg
Standard Deviation 645.18
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Noroxycodone(post dose8-12h)
|
1693.83 μg
Standard Deviation 978.49
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Noroxycodone(post dose12-24h)
|
2618.44 μg
Standard Deviation 1237.37
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hydroxymorphine(post dose0-2h)
|
6.13 μg
Standard Deviation 8.11
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hydroxymorphine(post dose2-4h)
|
30.16 μg
Standard Deviation 64.24
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hydroxymorphine(post dose4-8h)
|
54.68 μg
Standard Deviation 67.67
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hydroxymorphine(post dose8-12h)
|
72.85 μg
Standard Deviation 72.84
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hydroxymorphine(post dose12-24h)
|
108.81 μg
Standard Deviation 77.11
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Normethoxymorphone(post dose0-2h)
|
130.63 μg
Standard Deviation 100.61
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Normethoxymorphone(post dose2-4h)
|
338.90 μg
Standard Deviation 241.50
|
—
|
—
|
|
Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Normethoxymorphone(post dose12-24h)
|
796.81 μg
Standard Deviation 518.90
|
—
|
—
|
Adverse Events
Oxycodone Hydrochloride Single Dose(5mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Oxycodone Hydrochloride Single Dose(10mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Oxycodone Hydrochloride Single Dose(20mg)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Oxycodone Hydrochloride Multiple Dose(10mg)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxycodone Hydrochloride Single Dose(5mg)
n=15 participants at risk
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(10mg)
n=15 participants at risk
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Single Dose(20mg)
n=15 participants at risk
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
|
Oxycodone Hydrochloride Multiple Dose(10mg)
n=16 participants at risk
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 4 • 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.
No difference with the clinicaltrials.gov definition
|
66.7%
10/15 • Number of events 10 • 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.
No difference with the clinicaltrials.gov definition
|
93.3%
14/15 • Number of events 14 • 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.
No difference with the clinicaltrials.gov definition
|
25.0%
4/16 • Number of events 5 • 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.
No difference with the clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • 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.
No difference with the clinicaltrials.gov definition
|
33.3%
5/15 • Number of events 5 • 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.
No difference with the clinicaltrials.gov definition
|
66.7%
10/15 • Number of events 10 • 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.
No difference with the clinicaltrials.gov definition
|
25.0%
4/16 • Number of events 4 • 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.
No difference with the clinicaltrials.gov definition
|
|
Nervous system disorders
Drowsiness
|
26.7%
4/15 • Number of events 4 • 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.
No difference with the clinicaltrials.gov definition
|
20.0%
3/15 • Number of events 3 • 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.
No difference with the clinicaltrials.gov definition
|
33.3%
5/15 • Number of events 6 • 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.
No difference with the clinicaltrials.gov definition
|
0.00%
0/16 • 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.
No difference with the clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • 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.
No difference with the clinicaltrials.gov definition
|
20.0%
3/15 • Number of events 3 • 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.
No difference with the clinicaltrials.gov definition
|
46.7%
7/15 • Number of events 7 • 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.
No difference with the clinicaltrials.gov definition
|
37.5%
6/16 • Number of events 7 • 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.
No difference with the clinicaltrials.gov definition
|
Additional Information
Ms. Dan Zhu, Clinical operation and quality lead of the study
Mundipharma (China) Pharmaceutical Co.Ltd
Phone: +8610 6563 6891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60