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Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults

NCT00782548 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-16

No results posted yet for this study

Summary

The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30 mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed conditions.

The secondary objective of this study was to evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations

Conditions

  • Healthy

Interventions

DRUG

KADIAN (morphine sulfate sustained-release) capsules

Capsules, 30 mg

DRUG

Avinza (morphine sulfate sustained-release) capsules

Capsules, 30 mg

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Alan S. Marion, MD, PhD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-06-30
Completion
2004-06-30

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 NCT00782548 on ClinicalTrials.gov