drugset / Trial / NCT00853554

Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets

NCT00853554

Phase 1 Completed 24 enrolled Mallinckrodt
RandomizedCrossoverOpen-label

Summary

The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll Pharmaceutical Company) in a test group of healthy subjects under fasting conditions.

Timeline

Start
2002-12
Primary completion
2002-12
Completion
2002-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 8 mg Oral

Indications

No indication recorded.