Clinical trial · Interventional
Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients
NCT01482936CI-TRIAL-00018800completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone (OxyNorm®) Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxycodone (OxyNorm®) Injection
- description
- The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg
- interventionNames
- Drug: Oxycodone (OxyNorm®) Injection
Primary outcomes (1)
- measure
- Area under the curve (AUC) concentrations of oxycodone hydrochloride injection at various time points: predose, 0min, 2min, 5min, 10min, 15min, 30min, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post dose.
- timeFrame
- 2 days
- description
- Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases; * Patients aged \>30 to ≤ 60 years; * Body weight ≥ 45kg, and BMI range ≥19, \<24; * Karnofsky score ≥ 70; * Expected survival is above 3 months; * The results of liver function and kidney tests must meet the following criteria:ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25; * The electrocardiogram examination results are normal; * Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test. Exclusion Criteria: * Have hypersensitivity history to any opioids; * Have known hypersensitivity to any of compositions of the study drugs; * Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region; * Patients with respiratory depression, cor pulmonary, or chronic bronchial asthma; * Patient unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal; * Patients with hypercarbia; * Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency; * Patients with alcoholism or drug abuse history; * Positive ant-HIV or syphilis antibody test result; * Urine screening before study is positive for the opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids; * Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study. * Subjects who participated in a clinical research study within two months of study entry. * Patients who are currently taking opioids.
References
Publications (0)
Data not yet available
No reference posted for this study.