Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
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ClinicalTrials.gov Identifier: NCT00961116 |
Recruitment Status
:
Completed
First Posted
: August 18, 2009
Results First Posted
: October 1, 2009
Last Update Posted
: November 3, 2009
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Sponsor:
Mutual Pharmaceutical Company, Inc.
Information provided by:
Mutual Pharmaceutical Company, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | August 14, 2009 | |||
First Posted Date ICMJE | August 18, 2009 | |||
Results First Submitted Date | August 24, 2009 | |||
Results First Posted Date | October 1, 2009 | |||
Last Update Posted Date | November 3, 2009 | |||
Study Start Date ICMJE | October 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00961116 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate) | |||
Official Title ICMJE | A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg Tricor® (Fenofibrate) Tablets Under Fasting Conditions. | |||
Brief Summary | This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this regimen will also be evaluated. | |||
Detailed Description | Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of fenofibric acid and fenofibrate under fasting conditions. Additionally, the safety and tolerability of the study treatments will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens, fenofibric acid (Fibricor™) and fenofibrate (Tricor®) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid and fenofibrate. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms |
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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 |
54 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers | 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 | NCT00961116 | |||
Other Study ID Numbers ICMJE | MPC-028-07-1007 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Vice President, Branded products and Medical Affairs, Mutual Pharmaceutical Company, Inc. | |||
Study Sponsor ICMJE | Mutual Pharmaceutical Company, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mutual Pharmaceutical Company, Inc. | |||
Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |