Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

NCT00961259 | Completed Phase 1 Results

• 2 other identifiers: MPC-028-08-1017R08-0057
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Safety and tolerability of these regimens will also be evaluated.

Conditions

Healthy

Keywords

healthy; pharmacokinetics; therapeutic equivalency; fenofibric acid

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.

  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)]

  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. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the \[AUC(0-t)\] values were dose-adjusted in order to assess pharmacokinetic linearity.

  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 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. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.

  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 (3)

Fenofibric Acid 35 mg (1 x 35 mg tab)

EXPERIMENTAL

1 x 35 mg tablet administered after an overnight fast of at least 10 hours

Drug: Fenofibric Acid 35 mg Tablet

Fenofibric Acid 105 mg (3 x 35 mg tab)

EXPERIMENTAL

3 x 35 mg tablets administered after an overnight fast of at least 10 hours

Drug: Fenofibric Acid 35 mg Tablet

Fenofibric Acid 105 mg (1 x 105 mg tab)

EXPERIMENTAL

1 x 105 mg tablet administered after an overnight fast of at least 10 hours

Drug: Fenofibric Acid 105 mg Tablet

Interventions

Fenofibric Acid 35 mg Tablet DRUG

1 x 35 mg tablet administered after an overnight fast of at least 10 hours

Fenofibric Acid 35 mg (1 x 35 mg tab)

Fenofibric Acid 105 mg Tablet DRUG

105 mg tablet administered after an overnight fast of at least 10 hours

Fenofibric Acid 105 mg (1 x 105 mg tab)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 fenofibric acid

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

MeSH Terms

Interventions

fenofibric acid; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Anthony R Godfrey, Pharm.D.

  PRACS Institute

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 18, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 8, 2012
• Results First Posted: November 5, 2009

Record last verified: 2012-06