Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
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ClinicalTrials.gov Identifier: NCT00853892 |
Recruitment Status :
Completed
First Posted : March 2, 2009
Last Update Posted : September 9, 2016
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Sponsor:
Mallinckrodt
Information provided by:
Mallinckrodt
Tracking Information | |||
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First Submitted Date ICMJE | February 27, 2009 | ||
First Posted Date ICMJE | March 2, 2009 | ||
Last Update Posted Date | September 9, 2016 | ||
Study Start Date ICMJE | April 2005 | ||
Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Bioequivalence based on AUCf, AUCinf and Cmax [ Time Frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 36 hours. Washout period between doses was 7 days. ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets | ||
Official Title ICMJE | An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fasting Conditions | ||
Brief Summary | The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fasting conditions. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
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Condition ICMJE | Healthy | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
34 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | April 2005 | ||
Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00853892 | ||
Other Study ID Numbers ICMJE | 0595-05-812 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt | ||
Study Sponsor ICMJE | Mallinckrodt | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Mallinckrodt | ||
Verification Date | September 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |