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An Open-Label Study to Evaluate the Single Dose Pharmacokinetic Profile and Safety of OROS® Hydromorphone in Chinese Subjects With Cancer Who Are Not Opioid Tolerant
The purpose of this study is to assess the single dose pharmacokinetic profile (explores what a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of drug over time and higher doses of a drug are needed to get desired effect).
Details
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2011-12 |
| Completion | 2012-08 |
Conditions
- Pain
Interventions
- Hydromorphone
Primary outcomes
- Maximum Plasma Concentration (Cmax) — Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
The Cmax is the maximum observed plasma concentration of study drug. - Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours (AUC[0-48]) — Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
The AUC(0-48) is the area under the plasma concentration-time curve from time 0 to 48 hours post-dose. - Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-last]) — Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
The AUC(0-last) is area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. - Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) — Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
The AUC(0-infinity) is the area under the plasma concentration-time curve from time 0 to extrapolated infinite time, calculated as the sum of AUC(0-last) and C(last)/tau where C(last) is the last observed quantifiable concentration and 'tau' is the first-order rate constant associated with the terminal portion of the curve. - Percentage of AUC Obtained by Extrapolation (%AUC[inf,ex]) — Pre-dose, 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours post-dose
Percentage of AUC obtained by extrapolation (%AUC\[inf,ex\]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].
Countries
China