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

NCT00853554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-10-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Herbert Neuman, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2002-12-31
Completion
2002-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853554 on ClinicalTrials.gov