NCT00853554

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

An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Hydromorphone Hydrochloride (8 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (DILAUDID®, 8 mg Tablet, Knoll Pharmaceutical Company) in Normal Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Hydromorphone Hydrochloride tablet 8 mg	Hydromorphone Hydrochloride tablet 8 mg, single dose fasting
DRUG	Dilaudid® tablet 8 mg	Dilaudid® tablet 8 mg, single dose fasting

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2009-03-02
• Last updated: 2016-10-19

Locations

1 site across 1 country: United States