- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960856
Four Arm Food Effect Study of Fenofibric Acid Tablets
October 16, 2009 updated by: Mutual Pharmaceutical Company, Inc.
A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal
The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption.
Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption.
Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period.
On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence.
Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions.
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.
A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers.
Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose.
Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures.
All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute, Ltd. - Cetero Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults between the ages of 18 and 45
- 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 fenofibric acid
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fenofibric Acid 105 mg - Low-Fat Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
|
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
One 105 mg tablet administered after an overnight fast of at least 10 hours.
|
Experimental: Fenofibric Acid 105 mg - Standard Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast.
|
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
One 105 mg tablet administered after an overnight fast of at least 10 hours.
|
Experimental: Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
|
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
One 105 mg tablet administered after an overnight fast of at least 10 hours.
|
Experimental: Fenofibric Acid 105 mg - Fasted State
Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours
|
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
One 105 mg tablet administered after an overnight fast of at least 10 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Maximum Plasma Concentration (Cmax)
Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 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 dose administration
|
The maximum or peak concentration that the drug reaches in the plasma.
|
serial pharmacokinetic blood samples drawn immediately prior to dosing and then 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 dose administration
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 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 dose administration
|
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 blood samples drawn immediately prior to dosing and then 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 dose administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 17, 2009
First Posted (Estimate)
August 18, 2009
Study Record Updates
Last Update Posted (Estimate)
October 20, 2009
Last Update Submitted That Met QC Criteria
October 16, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPC-028-07-1009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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