An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg

Phase 1 Completed 32 enrolled Alza Corporation

RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study was to examine the OROSÂ® Hydromorphone HCL pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile for dose proportionality after administration of 8mg, 16mg, 32mg and 64 mg tablets.

Timeline

Start: —
Primary completion: —
Completion: 1998-09

Publications

Sathyan G, Xu E, Thipphawong J, Gupta SK. Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone. BMC Clin Pharmacol. 2007 Feb 2;7:3. doi: 10.1186/1472-6904-7-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydromorphone	Other / unclassified	8 mg	Oral
Subject	Hydromorphone	Other / unclassified	16 mg	Oral
Subject	Hydromorphone	Other / unclassified	32 mg	Oral
Subject	Hydromorphone	Other / unclassified	64 mg	Oral
Background	Naltrexone	Small molecule	50 mg	Oral

Indications

No indication recorded.