CompletedPhase 4

Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults

United States40 participantsStarted 2004-05

Plain-language 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

Who can participate

Age range19 Years – 40 Years

SexALL

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Inclusion criteria

✓. surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
✓. IUD in place for at least 3 months;
✓. barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
✓. surgical sterilization of the partner (vasectomy for 6 months minimum);
✓. hormonal contraceptives for at least 3 months prior to the first dose of the study.

Exclusion criteria

✕. alcoholism or drug abuse within the past 2 years;
✕. asthma or other chronic respiratory illness;
✕. gastrointestinal dysmobility or recent enteritis;
✕. hypersensitivity or idiosyncratic reaction to morphine or other opioids;
✕. hypersensitivity or idiosyncratic reaction to naltrexone, naloxone, or other narcotic antagonists.

What they're measuring

Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide

Timeframe: 60 hours post-dose

Trial details

NCT IDNCT00782548

SponsorActavis Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-06

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