An Open-Label Evaluation of the Independent Effects of Coadministration of

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Analgesia

Clinical Trial Details

NCT number	NCT00399295
Study type	Interventional
Source	Alza Corporation, DE, USA
Contact
Status	Completed
Phase	Phase 1
Completion date	June 1997

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05534230` - Dexmedetomidine for Pain Reduction in CABG	N/A
Recruiting	`NCT06275698` - HONEY for the Treatment of POst-Tonsillectomy Pain	N/A
Recruiting	`NCT04436224` - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation	Phase 4
Not yet recruiting	`NCT04548323` - Hypoalgesic Effects of Walking and Running Imagined
Completed	`NCT06054945` - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed	`NCT04394481` - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery	Phase 4
Completed	`NCT04690647` - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.	N/A
Completed	`NCT05034601` - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure	N/A
Completed	`NCT03740815` - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	N/A
Recruiting	`NCT05454202` - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting	`NCT04554186` - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.	N/A
Suspended	`NCT04860635` - Safety of F14 Following Total Knee Replacement	Phase 2/Phase 3
Not yet recruiting	`NCT06393777` - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion	N/A
Not yet recruiting	`NCT04519463` - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing	Early Phase 1
Completed	`NCT02916342` - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks	Phase 4
Not yet recruiting	`NCT02549118` - Tenoxicam for Intrapartum Analgesia	Phase 2
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Not yet recruiting	`NCT02190760` - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.	N/A
Completed	`NCT01789606` - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet	Phase 3
Completed	`NCT01299584` - ULTIVA Post Marketing Surveillance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms