Chronic Pain
Conditions
Keywords
Moderate to severe chronic non-malignant pain
Brief summary
This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese patients with moderate to severe chronic non-malignant pain.
Detailed description
It will be conducted to assess the pharmacokinetics of OXN 5/2.5 and OXN 20/10 tablets. Subjects will be allocated to a sequence of two strength group in accordance with a random allocation schedule (RAS) in a 1:1 ratio. Subjects will attend a screening visit within 14 days of the first (OXN) dosing day (Day 1). Eligible subjects will then check into the study unit on the day before OXN dosing (Day -2). Subjects will be administered their OXN dose the next 2 morning (Day 1), following an overnight fast.
Interventions
DRUGOXN PR tablet
Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
Sponsors
Mundipharma (China) Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult Chinese patients with moderate to severe chronic non-malignant pain. 2. Male and female subjects with age range 18 to 65 years (including 18 and 65), body weight ≥ 45kg and BMI range 18 to 30 (including 18 and 30). 3. Patients who should rate their pain (Pain Intensity Scale -average pain over the last 24 hours) as ≥4 on 0-10 scale. 4. Patients, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements. 5. Females of childbearing potential and less than one year post-menopausal must have a negative serum pregnancy test during screening visit and at check-in and be non-lactating. In addition, they must be willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
Exclusion criteria
1. Females who are pregnant (positive β-human chorionic gonadotrophin \[HCG\] test) or lactating. 2. Use of opioid or opioid antagonist-containing medication in the 30 days before the start of the study. 3. Known sensitivity to oxycodone, naloxone, or related compounds. 4. Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention (medication or surgical) or renal artery stenosis, or any other medical condition, that, in the opinion of the investigator or the sub-investigator, precludes entry into this study. 5. Subject who have a past (within 5 years) history of malignant neoplasm including leukemia and lymphoma. 6. The electrocardiogram examination results are abnormal, in the opinion of the investigator or the sub-investigator, and are clinical significance. 7. Subjects with abnormal liver function (values exceed the upper limit of normal for AST, ALT or total bilirubin during the Screening Period) or abnormal renal function (values exceed the upper limit of normal for serum creatinine during the Screening Period). 8. Patients with a contraindication to the study medication. 9. Subjects who have a psychiatric disorder such that participation in the study may, in the opinion of the investigator or the sub-investigator, pose an unacceptable risk to the subject. 10. Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors. 11. Subjects with uncontrolled seizures or convulsive disorder. 12. Subjects who will receive any interventional therapy (surgery, paracentesis,etc) for arthritis during the study period. 13. History of or any current conditions that might have interfered with drug absorption, distribution, metabolism or excretion. 14. Any history of frequent nausea or emesis regardless of aetiology. 15. Participation in any clinical drug study during the 3 months preceding the initial dose in this study. 16. Use of any medication including vitamins, herbal and/or mineral supplements during the course of the study, other than Vitamin D, calcium supplements and continued use by females of contraceptive medication or HRT. 17. Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol until at least 48 hours after the last study drug administration. 18. Blood or blood products donated within 90 days prior to study drug administration or anytime during the study, except as required by this protocol. 19. Positive results of urine drug screen(for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids), alcohol breath test, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Ab), human immunodeficiency virus (HIV) test or qualitative syphilis tests. 20. Patients with moderate to severe hypohemia (HGB\<90g/L during the screening).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-48hr of Noroxycodone Plasma Concentration. | 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. | AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed. |
| AUC0-t of Noroxycodone Plasma Concentration | 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. | 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. ) |
| AUC_%Extrap of Noroxycodone Plasma Concentration | 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. |
| AUCinf of Noroxycodone Plasma Concentration | 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. |
| Cmax of Noroxycodone Plasma Concentration | 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. |
| Lambda_z of Noroxycodone Plasma Concentration | 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. |
| T1/2 of Noroxycodone Plasma Concentration | 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. |
| Tmax of Noroxycodone Plasma Concentration | 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. |
| AUC0-48hr of Noroxymorphone Plasma Concentration | 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. |
| AUC0-t of Noroxymorphone Plasma Concentration | 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. |
| AUC_%Extrap of Noroxymorphone Plasma Concentration | 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. |
| AUCinf of Noroxymorphone Plasma Concentration | 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. |
| Cmax of Noroxymorphone Plasma Concentration | 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. |
| Lambda_z of Noroxymorphone Plasma Concentration | 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. |
| T1/2 of Noroxymorphone Plasma Concentration | 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. |
| Tmax of Noroxymorphone Plasma Concentration | 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. |
| AUC0-48hr of Oxycodone Plasma Concentration | 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. |
| AUC0-t of Oxycodone Plasma Concentration | 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. |
| AUC_%Extrap of Oxycodone Plasma Concentration | 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. |
| AUCinf of Oxycodone Plasma Concentration | 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. |
| Cmax of Oxycodone Plasma Concentration | 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. |
| Lambda_z of Oxycodone Plasma Concentration | 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. |
| T1/2 of Oxycodone Plasma Concentration | 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. |
| Tmax of Oxycodone Plasma Concentration | 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. |
| AUC0-48hr of Oxymorphone Plasma Concentration | 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. |
| AUC0-t of Oxymorphone Plasma Concentration | 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. |
| AUC_%Extrap of Oxymorphone Plasma Concentration | 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. |
| AUCinf of Oxymorphone Plasma Concentration | 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 Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Cmax of Oxymorphone Plasma Concentration | 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. |
| Lambda_z of Oxymorphone Plasma Concentration | 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 Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| T1/2 of Oxymorphone Plasma Concentration | 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 Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Tmax of Oxymorphone Plasma Concentration | 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. |
| AUC0-48hr of 6-B-Naloxol Plasma Concentration | 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. |
| AUC0-t of 6-B-Naloxol Plasma Concentration | 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. |
| AUC_%Extrap of 6-B-Naloxol Plasma Concentration | 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. |
| AUCinf of 6-B-Naloxol Plasma Concentration | 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 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Cmax of 6-B-Naloxol Plasma Concentration | 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. |
| Lambda_z of 6-B-Naloxol Plasma Concentration | 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 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| T1/2 of 6-B-Naloxol Plasma Concentration | 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 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Tmax of 6-B-Naloxol Plasma Concentration | 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. |
| AUC0-48hr of NLLG Plasma Concentration | 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. |
| AUC0-t of NLLG Plasma Concentration | 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. |
| AUC_%Extrap of NLLG Plasma Concentration | 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. |
| AUCinf of NLLG Plasma Concentration | 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 NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Cmax of NLLG Plasma Concentration | 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. |
| Lambda_z of NLLG Plasma Concentration | 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 NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| T1/2 of NLLG Plasma Concentration | 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 NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Tmax of NLLG Plasma Concentration | 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. |
| AUC0-48hr of NLXG Plasma Concentration | 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. |
| AUC0-t of NLXG Plasma Concentration | 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. |
| AUC_%Extrap of NLXG Plasma Concentration | 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. |
| AUCinf of NLXG Plasma Concentration | 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. |
| Cmax of NLXG Plasma Concentration | 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. |
| Lambda_z of NLXG Plasma Concentration | 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. |
| T1/2 of NLXG Plasma Concentration | 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. |
| Tmax of NLXG Plasma Concentration | 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. |
| AUC0-48hr of Naloxone Plasma Concentration | 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. |
| AUC0-t of Naloxone Plasma Concentration | 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. |
| AUC_%Extrap of Naloxone Plasma Concentration | 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. |
| AUCinf of Naloxone Plasma Concentration | 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 Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Cmax of Naloxone Plasma Concentration | 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. |
| Lambda_z of Naloxone Plasma Concentration | 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 Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| T1/2 of Naloxone Plasma Concentration | 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 Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed. |
| Tmax of Naloxone Plasma Concentration | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OXN PR Tablet 5/2.5 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 | 13 |
| 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 | 17 |
| Total | 30 |
Baseline characteristics
| Characteristic | OXN PR Tablet 20/10 mg | Total | OXN PR Tablet 5/2.5 mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 30 Participants | 13 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 17 participants | 30 participants | 13 participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 17 |
| other Total, other adverse events | 9 / 13 | 13 / 17 |
| serious Total, serious adverse events | 1 / 13 | 0 / 17 |
Outcome results
Primary
AUC0-48hr of 6-B-Naloxol Plasma Concentration
AUC0-48hr of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of 6-B-Naloxol Plasma Concentration | 1655.48 hr*pg/mL | Standard Deviation 667.02 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of 6-B-Naloxol Plasma Concentration | 5065.33 hr*pg/mL | Standard Deviation 3358.14 |
Primary
AUC0-48hr of Naloxone Plasma Concentration
AUC0-48hr of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of Naloxone Plasma Concentration | 281.91 hr*pg/mL | Standard Deviation 122.61 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of Naloxone Plasma Concentration | 650.42 hr*pg/mL | Standard Deviation 222.44 |
Primary
AUC0-48hr of NLLG Plasma Concentration
AUC0-48hr of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of NLLG Plasma Concentration | 57735.72 hr*pg/mL | Standard Deviation 24399.37 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of NLLG Plasma Concentration | 209514.4 hr*pg/mL | Standard Deviation 104345.5 |
Primary
AUC0-48hr of NLXG Plasma Concentration
AUC0-48hr of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of NLXG Plasma Concentration | 78725.81 hr*pg/mL | Standard Deviation 28285.24 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of NLXG Plasma Concentration | 320734.4 hr*pg/mL | Standard Deviation 113332.8 |
Primary
AUC0-48hr of Noroxycodone Plasma Concentration.
AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of Noroxycodone Plasma Concentration. | 81.72 hr*ng/mL | Standard Deviation 39.82 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of Noroxycodone Plasma Concentration. | 325.51 hr*ng/mL | Standard Deviation 99.47 |
Primary
AUC0-48hr of Noroxymorphone Plasma Concentration
AUC0-48hr of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of Noroxymorphone Plasma Concentration | 14.10 hr*ng/mL | Standard Deviation 5.02 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of Noroxymorphone Plasma Concentration | 65.84 hr*ng/mL | Standard Deviation 25.5 |
Primary
AUC0-48hr of Oxycodone Plasma Concentration
AUC0-48hr of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of Oxycodone Plasma Concentration | 89.48 hr*ng/mL | Standard Deviation 34.38 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of Oxycodone Plasma Concentration | 272.11 hr*ng/mL | Standard Deviation 48.51 |
Primary
AUC0-48hr of Oxymorphone Plasma Concentration
AUC0-48hr of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-48hr of Oxymorphone Plasma Concentration | 3.70 hr*ng/mL | Standard Deviation 1.33 |
| OXN PR Tablet 20/10 mg | AUC0-48hr of Oxymorphone Plasma Concentration | 3.59 hr*ng/mL | Standard Deviation 0.97 |
Primary
AUC0-t of 6-B-Naloxol Plasma Concentration
AUC0-t of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of 6-B-Naloxol Plasma Concentration | 1373.11 hr*pg/mL | Standard Deviation 779.63 |
| OXN PR Tablet 20/10 mg | AUC0-t of 6-B-Naloxol Plasma Concentration | 5049.62 hr*pg/mL | Standard Deviation 3374.52 |
Primary
AUC0-t of Naloxone Plasma Concentration
AUC0-t of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of Naloxone Plasma Concentration | 136.17 hr*pg/mL | Standard Deviation 92.95 |
| OXN PR Tablet 20/10 mg | AUC0-t of Naloxone Plasma Concentration | 443.88 hr*pg/mL | Standard Deviation 252.95 |
Primary
AUC0-t of NLLG Plasma Concentration
AUC0-t of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of NLLG Plasma Concentration | 57737.49 hr*pg/mL | Standard Deviation 24400.8 |
| OXN PR Tablet 20/10 mg | AUC0-t of NLLG Plasma Concentration | 209514.4 hr*pg/mL | Standard Deviation 104345.5 |
Primary
AUC0-t of NLXG Plasma Concentration
AUC0-t of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of NLXG Plasma Concentration | 77976.24 hr*pg/mL | Standard Deviation 28477.82 |
| OXN PR Tablet 20/10 mg | AUC0-t of NLXG Plasma Concentration | 320734.4 hr*pg/mL | Standard Deviation 113332.8 |
Primary
AUC0-t of Noroxycodone Plasma Concentration
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. )
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of Noroxycodone Plasma Concentration | 81.25 hr*ng/mL | Standard Deviation 40.27 |
| OXN PR Tablet 20/10 mg | AUC0-t of Noroxycodone Plasma Concentration | 325.37 hr*ng/mL | Standard Deviation 99.76 |
Primary
AUC0-t of Noroxymorphone Plasma Concentration
AUC0-t of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of Noroxymorphone Plasma Concentration | 12.92 hr*ng/mL | Standard Deviation 5.21 |
| OXN PR Tablet 20/10 mg | AUC0-t of Noroxymorphone Plasma Concentration | 65.65 hr*ng/mL | Standard Deviation 25.78 |
Primary
AUC0-t of Oxycodone Plasma Concentration
AUC0-t of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of Oxycodone Plasma Concentration | 88.45 hr*ng/mL | Standard Deviation 34.55 |
| OXN PR Tablet 20/10 mg | AUC0-t of Oxycodone Plasma Concentration | 271.21 hr*ng/mL | Standard Deviation 48.79 |
Primary
AUC0-t of Oxymorphone Plasma Concentration
AUC0-t of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC0-t of Oxymorphone Plasma Concentration | 0.14 hr*ng/mL | Standard Deviation 0.33 |
| OXN PR Tablet 20/10 mg | AUC0-t of Oxymorphone Plasma Concentration | 1.66 hr*ng/mL | Standard Deviation 1.21 |
Primary
AUC_%Extrap of 6-B-Naloxol Plasma Concentration
AUC\_%Extrap of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of 6-B-Naloxol Plasma Concentration | 21.24 (%) | Standard Deviation 15.98 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of 6-B-Naloxol Plasma Concentration | 33.37 (%) | Standard Deviation 15.6 |
Primary
AUC_%Extrap of Naloxone Plasma Concentration
AUC\_%Extrap of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of Naloxone Plasma Concentration | 47.82 (%) | Standard Deviation 20.95 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of Naloxone Plasma Concentration | 44.94 (%) | Standard Deviation 26.95 |
Primary
AUC_%Extrap of NLLG Plasma Concentration
AUC\_%Extrap of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of NLLG Plasma Concentration | 13.13 (%) | Standard Deviation 14.09 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of NLLG Plasma Concentration | 20.07 (%) | Standard Deviation 9.23 |
Primary
AUC_%Extrap of NLXG Plasma Concentration
AUC\_%Extrap of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of NLXG Plasma Concentration | 1.56 (%) | Standard Deviation 1.05 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of NLXG Plasma Concentration | 1.86 (%) | Standard Deviation 1.39 |
Primary
AUC_%Extrap of Noroxycodone Plasma Concentration
AUC\_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of Noroxycodone Plasma Concentration | 2.99 (%) | Standard Deviation 1.17 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of Noroxycodone Plasma Concentration | 1.45 (%) | Standard Deviation 0.67 |
Primary
AUC_%Extrap of Noroxymorphone Plasma Concentration
AUC\_%Extrap of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of Noroxymorphone Plasma Concentration | 14.89 (%) | Standard Deviation 11.61 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of Noroxymorphone Plasma Concentration | 4.25 (%) | Standard Deviation 1.98 |
Primary
AUC_%Extrap of Oxycodone Plasma Concentration
AUC\_%Extrap of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of Oxycodone Plasma Concentration | 1.78 (%) | Standard Deviation 1.15 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of Oxycodone Plasma Concentration | 0.57 (%) | Standard Deviation 0.21 |
Primary
AUC_%Extrap of Oxymorphone Plasma Concentration
AUC\_%Extrap of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUC_%Extrap of Oxymorphone Plasma Concentration | 82.85 (%) | Standard Deviation 21.51 |
| OXN PR Tablet 20/10 mg | AUC_%Extrap of Oxymorphone Plasma Concentration | 51.11 (%) | Standard Deviation 26.7 |
Primary
AUCinf of 6-B-Naloxol Plasma Concentration
AUCinf of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of 6-B-Naloxol Plasma Concentration | 1828.39 hr*pg/mL | Standard Deviation 878.66 |
Primary
AUCinf of Naloxone Plasma Concentration
AUCinf of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
AUCinf of NLLG Plasma Concentration
AUCinf of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of NLLG Plasma Concentration | 62953.71 hr*pg/mL | Standard Deviation 26257.03 |
Primary
AUCinf of NLXG Plasma Concentration
AUCinf of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of NLXG Plasma Concentration | 79025.78 hr*pg/mL | Standard Deviation 28389.19 |
| OXN PR Tablet 20/10 mg | AUCinf of NLXG Plasma Concentration | 326907.3 hr*pg/mL | Standard Deviation 115103.6 |
Primary
AUCinf of Noroxycodone Plasma Concentration
AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of Noroxycodone Plasma Concentration | 83.74 hr*ng/mL | Standard Deviation 41.66 |
| OXN PR Tablet 20/10 mg | AUCinf of Noroxycodone Plasma Concentration | 330.44 hr*ng/mL | Standard Deviation 102.51 |
Primary
AUCinf of Noroxymorphone Plasma Concentration
AUCinf of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of Noroxymorphone Plasma Concentration | 15.76 hr*ng/mL | Standard Deviation 4.68 |
| OXN PR Tablet 20/10 mg | AUCinf of Noroxymorphone Plasma Concentration | 68.17 hr*ng/mL | Standard Deviation 26.22 |
Primary
AUCinf of Oxycodone Plasma Concentration
AUCinf of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | AUCinf of Oxycodone Plasma Concentration | 89.85 hr*ng/mL | Standard Deviation 34.72 |
| OXN PR Tablet 20/10 mg | AUCinf of Oxycodone Plasma Concentration | 272.71 hr*ng/mL | Standard Deviation 48.77 |
Primary
AUCinf of Oxymorphone Plasma Concentration
AUCinf of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
Cmax of 6-B-Naloxol Plasma Concentration
Cmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of 6-B-Naloxol Plasma Concentration | 85.18 pg/mL | Standard Deviation 47.25 |
| OXN PR Tablet 20/10 mg | Cmax of 6-B-Naloxol Plasma Concentration | 269.53 pg/mL | Standard Deviation 189.5 |
Primary
Cmax of Naloxone Plasma Concentration
Cmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of Naloxone Plasma Concentration | 33.21 pg/mL | Standard Deviation 24.62 |
| OXN PR Tablet 20/10 mg | Cmax of Naloxone Plasma Concentration | 45.10 pg/mL | Standard Deviation 21.03 |
Primary
Cmax of NLLG Plasma Concentration
Cmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of NLLG Plasma Concentration | 3442.63 pg/mL | Standard Deviation 1800.17 |
| OXN PR Tablet 20/10 mg | Cmax of NLLG Plasma Concentration | 11372.74 pg/mL | Standard Deviation 5426.77 |
Primary
Cmax of NLXG Plasma Concentration
Cmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of NLXG Plasma Concentration | 11488.62 pg/mL | Standard Deviation 2493.48 |
| OXN PR Tablet 20/10 mg | Cmax of NLXG Plasma Concentration | 45789.83 pg/mL | Standard Deviation 10576 |
Primary
Cmax of Noroxycodone Plasma Concentration
Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of Noroxycodone Plasma Concentration | 4.68 ng/mL | Standard Deviation 1.53 |
| OXN PR Tablet 20/10 mg | Cmax of Noroxycodone Plasma Concentration | 20.69 ng/mL | Standard Deviation 3.88 |
Primary
Cmax of Noroxymorphone Plasma Concentration
Cmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of Noroxymorphone Plasma Concentration | 0.75 ng/mL | Standard Deviation 0.29 |
| OXN PR Tablet 20/10 mg | Cmax of Noroxymorphone Plasma Concentration | 3.54 ng/mL | Standard Deviation 1.64 |
Primary
Cmax of Oxycodone Plasma Concentration
Cmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of Oxycodone Plasma Concentration | 6.69 ng/mL | Standard Deviation 1.67 |
| OXN PR Tablet 20/10 mg | Cmax of Oxycodone Plasma Concentration | 24.64 ng/mL | Standard Deviation 6.3 |
Primary
Cmax of Oxymorphone Plasma Concentration
Cmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Cmax of Oxymorphone Plasma Concentration | 0.03 ng/mL | Standard Deviation 0.06 |
| OXN PR Tablet 20/10 mg | Cmax of Oxymorphone Plasma Concentration | 0.30 ng/mL | Standard Deviation 0.17 |
Primary
Lambda_z of 6-B-Naloxol Plasma Concentration
Lambda\_z of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of 6-B-Naloxol Plasma Concentration | 0.07 1/hr | Standard Deviation 0.02 |
Primary
Lambda_z of Naloxone Plasma Concentration
Lambda\_z of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
Lambda_z of NLLG Plasma Concentration
Lambda\_z of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of NLLG Plasma Concentration | 0.07 1/hr | Standard Deviation 0.02 |
Primary
Lambda_z of NLXG Plasma Concentration
Lambda\_z of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of NLXG Plasma Concentration | 0.14 1/hr | Standard Deviation 0.03 |
| OXN PR Tablet 20/10 mg | Lambda_z of NLXG Plasma Concentration | 0.09 1/hr | Standard Deviation 0.03 |
Primary
Lambda_z of Noroxycodone Plasma Concentration
Lambda\_z of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of Noroxycodone Plasma Concentration | 0.10 1/hr | Standard Deviation 0.02 |
| OXN PR Tablet 20/10 mg | Lambda_z of Noroxycodone Plasma Concentration | 0.10 1/hr | Standard Deviation 0.01 |
Primary
Lambda_z of Noroxymorphone Plasma Concentration
Lambda\_z of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of Noroxymorphone Plasma Concentration | 0.08 1/hr | Standard Deviation 0.02 |
| OXN PR Tablet 20/10 mg | Lambda_z of Noroxymorphone Plasma Concentration | 0.08 1/hr | Standard Deviation 0.01 |
Primary
Lambda_z of Oxycodone Plasma Concentration
Lambda\_z of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | Lambda_z of Oxycodone Plasma Concentration | 0.14 1/hr | Standard Deviation 0.04 |
| OXN PR Tablet 20/10 mg | Lambda_z of Oxycodone Plasma Concentration | 0.14 1/hr | Standard Deviation 0.02 |
Primary
Lambda_z of Oxymorphone Plasma Concentration
Lambda\_z of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
T1/2 of 6-B-Naloxol Plasma Concentration
T1/2 of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of 6-B-Naloxol Plasma Concentration | 9.78 hr | Standard Deviation 2.2 |
Primary
T1/2 of Naloxone Plasma Concentration
T1/2 of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
T1/2 of NLLG Plasma Concentration
T1/2 of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of NLLG Plasma Concentration | 11.32 hr | Standard Deviation 4.26 |
Primary
T1/2 of NLXG Plasma Concentration
T1/2 of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of NLXG Plasma Concentration | 5.28 hr | Standard Deviation 1.35 |
| OXN PR Tablet 20/10 mg | T1/2 of NLXG Plasma Concentration | 8.40 hr | Standard Deviation 2.43 |
Primary
T1/2 of Noroxycodone Plasma Concentration
T1/2 of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of Noroxycodone Plasma Concentration | 7.42 hr | Standard Deviation 1.42 |
| OXN PR Tablet 20/10 mg | T1/2 of Noroxycodone Plasma Concentration | 7.16 hr | Standard Deviation 1.02 |
Primary
T1/2 of Noroxymorphone Plasma Concentration
T1/2 of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of Noroxymorphone Plasma Concentration | 8.55 hr | Standard Deviation 1.53 |
| OXN PR Tablet 20/10 mg | T1/2 of Noroxymorphone Plasma Concentration | 9.08 hr | Standard Deviation 1.42 |
Primary
T1/2 of Oxycodone Plasma Concentration
T1/2 of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OXN PR Tablet 5/2.5 mg | T1/2 of Oxycodone Plasma Concentration | 5.09 hr | Standard Deviation 0.96 |
| OXN PR Tablet 20/10 mg | T1/2 of Oxycodone Plasma Concentration | 5.03 hr | Standard Deviation 0.69 |
Primary
T1/2 of Oxymorphone Plasma Concentration
T1/2 of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
Primary
Tmax of 6-B-Naloxol Plasma Concentration
Tmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of 6-B-Naloxol Plasma Concentration | 6.50 hr |
| OXN PR Tablet 20/10 mg | Tmax of 6-B-Naloxol Plasma Concentration | 1.75 hr |
Primary
Tmax of Naloxone Plasma Concentration
Tmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of Naloxone Plasma Concentration | 8.00 hr |
| OXN PR Tablet 20/10 mg | Tmax of Naloxone Plasma Concentration | 1.00 hr |
Primary
Tmax of NLLG Plasma Concentration
Tmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of NLLG Plasma Concentration | 11.00 hr |
| OXN PR Tablet 20/10 mg | Tmax of NLLG Plasma Concentration | 1.50 hr |
Primary
Tmax of NLXG Plasma Concentration
Tmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of NLXG Plasma Concentration | 1.01 hr |
| OXN PR Tablet 20/10 mg | Tmax of NLXG Plasma Concentration | 1.25 hr |
Primary
Tmax of Noroxycodone Plasma Concentration
Tmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of Noroxycodone Plasma Concentration | 4.50 hr |
| OXN PR Tablet 20/10 mg | Tmax of Noroxycodone Plasma Concentration | 4.00 hr |
Primary
Tmax of Noroxymorphone Plasma Concentration
Tmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of Noroxymorphone Plasma Concentration | 7.00 hr |
| OXN PR Tablet 20/10 mg | Tmax of Noroxymorphone Plasma Concentration | 5.00 hr |
Primary
Tmax of Oxycodone Plasma Concentration
Tmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of Oxycodone Plasma Concentration | 3.75 hr |
| OXN PR Tablet 20/10 mg | Tmax of Oxycodone Plasma Concentration | 2.00 hr |
Primary
Tmax of Oxymorphone Plasma Concentration
Tmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OXN PR Tablet 5/2.5 mg | Tmax of Oxymorphone Plasma Concentration | 0.75 hr |
| OXN PR Tablet 20/10 mg | Tmax of Oxymorphone Plasma Concentration | 1.75 hr |