Last reviewed · How we verify
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.
Details
| Lead sponsor | Mutual Pharmaceutical Company, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2007-11 |
| Completion | 2007-11 |
Conditions
- Healthy
Interventions
- Fenofibric Acid 105 mg Tablet
- Fenofibric Acid 105 mg Tablet
- Fenofibric Acid 105 mg Tablet
- Fenofibric Acid 105 mg Tablet
Primary outcomes
- Maximum Plasma Concentration (Cmax) — 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. - Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] — 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. - The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) — 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.
Countries
United States