Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT00399295
Brief Summary:
The purpose of this study was to compare the pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic profile of Dilaudid SR.
Detailed Description:
This was a randomized (patients are assigned different treatments based on chance), open-label, three-way crossover study, performed in normal, healthy adults. Each patient received orally administered treatments (a different treatment during each dosing phase): Treatment A: single dose of Dilaudid SR 16 mg administered under fasting conditions without the naltrexone block;Treatment B: single dose of Dilaudid SR 16 mg administered under fed conditions without the naltrexone block, Treatment C: single dose of Dilaudid SR 16 mg administered under fasting conditions with naltrexone HCL 50mg block (3 oral doses of 50mg each administered 12 hours prior to , at the time of, and 12 hours after Dilaudid SR 16mg administration). There was a 7-day washout period between dosing phases.
Venous blood sampling times were 0 (prior to dosing),2,4,6,8,10,12,16,20,24,30,36,42,and 48 hours after each Dilaudid SR administration. LC/MS/MS (Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy)techniques were employed for the analysis of plasma for hydromorphone concentration. Each patient randomly received orally-administered treatments of single dose of Dilaudid SR 16mg; under fasting conditions without the naltrexone block; under fed conditions without naltrexone block; under fasting conditions with naltrexone 50mg block (3 oral doses of 50mg naltrexone HCL each administered 12 hours prior to, at the time of, and 12 hours after hydromorphone administration); 7-day washout period between dosing phases.
Study:
NCT00399295
Study Brief:
Protocol Section:
NCT00399295