Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

Tracking Information
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; (submitted: August 24, 2009)	Maximum Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]; Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]; The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]
Original Primary Outcome Measures ICMJE; (submitted: August 17, 2009)	Bioequivalence (Cmax) [ Time Frame: Days 1 and 7 ]; Bioequivalence (AUC 0-t) [ Time Frame: Days 1 and 7 ]; Bioequivalence [AUC(0-∞)] [ Time Frame: Days 1 and 7 ]
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
Condition ICMJE	Healthy
Intervention ICMJE	Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet 1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours Other Name: (Fibricor™); Drug: Fenofibrate (Tricor®) 145 mg Tablet 1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours Other Name: (Tricor®)
Study Arms	Experimental: Fenofibric Acid (Fibricor™) 1 x 105 mg fenofibric acid (Fibricor™)tablet administered after an overnight fast of at least 10 hours Intervention: Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet; Experimental: Fenofibrate (Tricor®) 1 x 145 mg fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours Intervention: Drug: Fenofibrate (Tricor®) 145 mg Tablet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 17, 2009)	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: Healthy adults 18-45 years of age; Non-smoking; Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures); Body mass index (BMI) less than 30; Medically healthy on the basis of medical history and physical examination; Hemoglobin > or = to 12g/dL; Completion of the screening process within 28 days prior to dosing; Provision of voluntary written informed consent Exclusion Criteria: Recent participation (within 28 days) in other research studies; Recent significant blood donation or plasma donation; Pregnant or lactating; Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV); Recent (2-year) history or evidence of alcoholism or drug abuse; History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study; Drug allergies to fenofibrate (fenofibric acid)
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Anthony R Godfrey, Pharm.D. PRACS - Cetero
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