An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg
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|ClinicalTrials.gov Identifier: NCT00398957|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : April 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Analgesia||Drug: OROS® Hydromorphone HCL; OROS® Dilaudid; Dilaudid SR (slow release); Naltrexone (an opioid antagonist).||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Evaluation of the Dose Proportionality of Dilaudid SR (OROS� Hydromorphone HCL) Tablets 8mg, 16mg, 32mg, and 64mg|
|Actual Study Completion Date :||September 1998|
- The primary endpoints for the statistical evaluations of the study drug were: Area Under the Concentration-Time Curve from 0 to Infinity, Area Under the Concentration-Time Curve from 0 to time t and Peak Plasma Concentration.
- The secondary endpoints were the pharmacokinetic parameters for the study drug: Time to Peak Plasma Concentration and Terminal half-life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398957
|Study Director:||Alza Corporation Clinical Trial||ALZA|