Trial Outcomes & Findings for OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients (NCT NCT02880475)
NCT ID: NCT02880475
Last Updated: 2019-07-17
Results Overview
AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.
Results posted on
2019-07-17
Participant Flow
Participant milestones
| Measure |
OXN Prolonged Release Tablet 5/2.5 mg
The subjects were randomized to receive a single dose of OXN prolonged release tablets 5/2.5mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg
|
OXN Prolonged Release Tablet 20/10 mg
The subjects were randomized to receive a single dose of OXN prolonged release tablets 20/10mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 20/10 mg
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OXN PR Tablet 5/2.5 mg
n=13 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=17 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
17 Participants
n=17 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
8 Participants
n=17 Participants
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
9 Participants
n=17 Participants
|
15 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
13 participants
n=13 Participants
|
17 participants
n=17 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.Population: 12 subjects in OXN PR tablet 5/2.5 mg group,12 subjects in OXN PR tablet 20/10 mg group.
AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of Noroxycodone Plasma Concentration.
|
81.72 hr*ng/mL
Standard Deviation 39.82
|
325.51 hr*ng/mL
Standard Deviation 99.47
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.Population: 12 subjects in OXN PR tablet 5/2.5 mg group,12 subjects in OXN PR tablet 20/10 mg group.
AUC0-t of Noroxycodone plasma concentration.Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed .(If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis. )
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of Noroxycodone Plasma Concentration
|
81.25 hr*ng/mL
Standard Deviation 40.27
|
325.37 hr*ng/mL
Standard Deviation 99.76
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of Noroxycodone Plasma Concentration
|
2.99 (%)
Standard Deviation 1.17
|
1.45 (%)
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of Noroxycodone Plasma Concentration
|
83.74 hr*ng/mL
Standard Deviation 41.66
|
330.44 hr*ng/mL
Standard Deviation 102.51
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of Noroxycodone Plasma Concentration
|
4.68 ng/mL
Standard Deviation 1.53
|
20.69 ng/mL
Standard Deviation 3.88
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Lambda\_z of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of Noroxycodone Plasma Concentration
|
0.10 1/hr
Standard Deviation 0.02
|
0.10 1/hr
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.T1/2 of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of Noroxycodone Plasma Concentration
|
7.42 hr
Standard Deviation 1.42
|
7.16 hr
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of Noroxycodone Plasma Concentration
|
4.50 hr
Interval 1.5 to 8.02
|
4.00 hr
Interval 2.5 to 5.02
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of Noroxymorphone Plasma Concentration
|
14.10 hr*ng/mL
Standard Deviation 5.02
|
65.84 hr*ng/mL
Standard Deviation 25.50
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of Noroxymorphone Plasma Concentration
|
12.92 hr*ng/mL
Standard Deviation 5.21
|
65.65 hr*ng/mL
Standard Deviation 25.78
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of Noroxymorphone Plasma Concentration
|
14.89 (%)
Standard Deviation 11.61
|
4.25 (%)
Standard Deviation 1.98
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUCinf of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of Noroxymorphone Plasma Concentration
|
15.76 hr*ng/mL
Standard Deviation 4.68
|
68.17 hr*ng/mL
Standard Deviation 26.22
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of Noroxymorphone Plasma Concentration
|
0.75 ng/mL
Standard Deviation 0.29
|
3.54 ng/mL
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Lambda\_z of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of Noroxymorphone Plasma Concentration
|
0.08 1/hr
Standard Deviation 0.02
|
0.08 1/hr
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.T1/2 of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of Noroxymorphone Plasma Concentration
|
8.55 hr
Standard Deviation 1.53
|
9.08 hr
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of Noroxymorphone Plasma Concentration
|
7.00 hr
Interval 2.0 to 10.0
|
5.00 hr
Interval 2.5 to 7.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of Oxycodone Plasma Concentration
|
89.48 hr*ng/mL
Standard Deviation 34.38
|
272.11 hr*ng/mL
Standard Deviation 48.51
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of Oxycodone Plasma Concentration
|
88.45 hr*ng/mL
Standard Deviation 34.55
|
271.21 hr*ng/mL
Standard Deviation 48.79
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of Oxycodone Plasma Concentration
|
1.78 (%)
Standard Deviation 1.15
|
0.57 (%)
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUCinf of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of Oxycodone Plasma Concentration
|
89.85 hr*ng/mL
Standard Deviation 34.72
|
272.71 hr*ng/mL
Standard Deviation 48.77
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of Oxycodone Plasma Concentration
|
6.69 ng/mL
Standard Deviation 1.67
|
24.64 ng/mL
Standard Deviation 6.30
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Lambda\_z of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of Oxycodone Plasma Concentration
|
0.14 1/hr
Standard Deviation 0.04
|
0.14 1/hr
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.T1/2 of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of Oxycodone Plasma Concentration
|
5.09 hr
Standard Deviation 0.96
|
5.03 hr
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of Oxycodone Plasma Concentration
|
3.75 hr
Interval 1.02 to 8.0
|
2.00 hr
Interval 0.5 to 5.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of Oxymorphone Plasma Concentration
|
3.70 hr*ng/mL
Standard Deviation 1.33
|
3.59 hr*ng/mL
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of Oxymorphone Plasma Concentration
|
0.14 hr*ng/mL
Standard Deviation 0.33
|
1.66 hr*ng/mL
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of Oxymorphone Plasma Concentration
|
82.85 (%)
Standard Deviation 21.51
|
51.11 (%)
Standard Deviation 26.70
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
AUCinf of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of Oxymorphone Plasma Concentration
|
0.03 ng/mL
Standard Deviation 0.06
|
0.30 ng/mL
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
Lambda\_z of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
T1/2 of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of Oxymorphone Plasma Concentration
|
0.75 hr
Interval 0.5 to 1.0
|
1.75 hr
Interval 0.5 to 5.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of 6-B-Naloxol Plasma Concentration
|
1655.48 hr*pg/mL
Standard Deviation 667.02
|
5065.33 hr*pg/mL
Standard Deviation 3358.14
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of 6-B-Naloxol Plasma Concentration
|
1373.11 hr*pg/mL
Standard Deviation 779.63
|
5049.62 hr*pg/mL
Standard Deviation 3374.52
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of 6-B-Naloxol Plasma Concentration
|
21.24 (%)
Standard Deviation 15.98
|
33.37 (%)
Standard Deviation 15.60
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
AUCinf of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of 6-B-Naloxol Plasma Concentration
|
1828.39 hr*pg/mL
Standard Deviation 878.66
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of 6-B-Naloxol Plasma Concentration
|
85.18 pg/mL
Standard Deviation 47.25
|
269.53 pg/mL
Standard Deviation 189.50
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
Lambda\_z of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of 6-B-Naloxol Plasma Concentration
|
0.07 1/hr
Standard Deviation 0.02
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
T1/2 of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of 6-B-Naloxol Plasma Concentration
|
9.78 hr
Standard Deviation 2.20
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of 6-B-Naloxol Plasma Concentration
|
6.50 hr
Interval 0.5 to 14.0
|
1.75 hr
Interval 0.5 to 12.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of NLLG Plasma Concentration
|
57735.72 hr*pg/mL
Standard Deviation 24399.37
|
209514.4 hr*pg/mL
Standard Deviation 104345.5
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of NLLG Plasma Concentration
|
57737.49 hr*pg/mL
Standard Deviation 24400.80
|
209514.4 hr*pg/mL
Standard Deviation 104345.5
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of NLLG Plasma Concentration
|
13.13 (%)
Standard Deviation 14.09
|
20.07 (%)
Standard Deviation 9.23
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
AUCinf of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of NLLG Plasma Concentration
|
62953.71 hr*pg/mL
Standard Deviation 26257.03
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of NLLG Plasma Concentration
|
3442.63 pg/mL
Standard Deviation 1800.17
|
11372.74 pg/mL
Standard Deviation 5426.77
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
Lambda\_z of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of NLLG Plasma Concentration
|
0.07 1/hr
Standard Deviation 0.02
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
T1/2 of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of NLLG Plasma Concentration
|
11.32 hr
Standard Deviation 4.26
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of NLLG Plasma Concentration
|
11.00 hr
Interval 0.5 to 14.0
|
1.50 hr
Interval 0.5 to 7.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of NLXG Plasma Concentration
|
78725.81 hr*pg/mL
Standard Deviation 28285.24
|
320734.4 hr*pg/mL
Standard Deviation 113332.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of NLXG Plasma Concentration
|
77976.24 hr*pg/mL
Standard Deviation 28477.82
|
320734.4 hr*pg/mL
Standard Deviation 113332.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of NLXG Plasma Concentration
|
1.56 (%)
Standard Deviation 1.05
|
1.86 (%)
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUCinf of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUCinf of NLXG Plasma Concentration
|
79025.78 hr*pg/mL
Standard Deviation 28389.19
|
326907.3 hr*pg/mL
Standard Deviation 115103.6
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of NLXG Plasma Concentration
|
11488.62 pg/mL
Standard Deviation 2493.48
|
45789.83 pg/mL
Standard Deviation 10576.00
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Lambda\_z of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Lambda_z of NLXG Plasma Concentration
|
0.14 1/hr
Standard Deviation 0.03
|
0.09 1/hr
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.T1/2 of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
T1/2 of NLXG Plasma Concentration
|
5.28 hr
Standard Deviation 1.35
|
8.40 hr
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of NLXG Plasma Concentration
|
1.01 hr
Interval 0.5 to 8.0
|
1.25 hr
Interval 0.5 to 3.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-48hr of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-48hr of Naloxone Plasma Concentration
|
281.91 hr*pg/mL
Standard Deviation 122.61
|
650.42 hr*pg/mL
Standard Deviation 222.44
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC0-t of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC0-t of Naloxone Plasma Concentration
|
136.17 hr*pg/mL
Standard Deviation 92.95
|
443.88 hr*pg/mL
Standard Deviation 252.95
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.AUC\_%Extrap of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
AUC_%Extrap of Naloxone Plasma Concentration
|
47.82 (%)
Standard Deviation 20.95
|
44.94 (%)
Standard Deviation 26.95
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
AUCinf of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Cmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Cmax of Naloxone Plasma Concentration
|
33.21 pg/mL
Standard Deviation 24.62
|
45.10 pg/mL
Standard Deviation 21.03
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
Lambda\_z of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Population: If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis.
T1/2 of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.Tmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Outcome measures
| Measure |
OXN PR Tablet 5/2.5 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=12 Participants
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Tmax of Naloxone Plasma Concentration
|
8.00 hr
Interval 5.0 to 14.0
|
1.00 hr
Interval 0.5 to 8.0
|
Adverse Events
OXN PR Tablet 5/2.5 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
OXN PR Tablet 20/10 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OXN PR Tablet 5/2.5 mg
n=13 participants at risk
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=17 participants at risk
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Infections and infestations
upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
0.00%
0/17 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
Other adverse events
| Measure |
OXN PR Tablet 5/2.5 mg
n=13 participants at risk
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
OXN PR Tablet 20/10 mg
n=17 participants at risk
The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.
OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
15.4%
2/13 • Number of events 2 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Infections and infestations
upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Investigations
Elevated aminotransferase
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
0.00%
0/17 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Nervous system disorders
Sleepiness
|
30.8%
4/13 • Number of events 4 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
35.3%
6/17 • Number of events 6 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Nervous system disorders
headache
|
23.1%
3/13 • Number of events 3 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Nervous system disorders
dizziness
|
15.4%
2/13 • Number of events 2 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
29.4%
5/17 • Number of events 5 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Nervous system disorders
vertigo
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Nervous system disorders
Imbalance of autonomic nervous system
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
0.00%
0/17 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Respiratory, thoracic and mediastinal disorders
dry pharynx
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
11.8%
2/17 • Number of events 2 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
General disorders
flushing
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
General disorders
fatigue
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
General disorders
cold sweat
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
constipation
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
29.4%
5/17 • Number of events 5 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
abdominal distension
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
11.8%
2/17 • Number of events 2 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
0.00%
0/17 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
vomit
|
7.7%
1/13 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
29.4%
5/17 • Number of events 5 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
Difficult defecation
|
23.1%
3/13 • Number of events 3 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
17.6%
3/17 • Number of events 3 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
|
Cardiac disorders
palpitation
|
0.00%
0/13 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
5.9%
1/17 • Number of events 1 • Events will be recorded from the point at which the Informed Consent is signed until 7(+3) days after the subject leaves the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place