Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg Tricor® (Fenofibrate) Tablets Under Fasting Conditions.
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Oct 2007
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedResults Posted
Study results publicly available
October 1, 2009
CompletedNovember 3, 2009
October 1, 2009
1 month
August 14, 2009
August 24, 2009
October 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
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)]
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
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-∞)
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
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.
Study Arms (2)
Fenofibric Acid (Fibricor™)
EXPERIMENTAL1 x 105 mg fenofibric acid (Fibricor™)tablet administered after an overnight fast of at least 10 hours
Fenofibrate (Tricor®)
EXPERIMENTAL1 x 145 mg fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours
Interventions
1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours
1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, 58104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Mutual Pharmaceutical Company, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony R Godfrey, Pharm.D.
PRACS - Cetero
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 18, 2009
Study Start
October 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
November 3, 2009
Results First Posted
October 1, 2009
Record last verified: 2009-10