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A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg TriCor® (Fenofibrate) Tablets Under Fed Conditions(Standard Meal)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.
Details
| Lead sponsor | Mutual Pharmaceutical Company, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 2007-10 |
| Completion | 2007-11 |
Conditions
- Healthy
Interventions
- Fenofibric Acid (Fibricor™) 105 mg Tablet
- Fenofibrate (Tricor®) 145 mg Tablet
Primary outcomes
- Maximum Plasma Concentration (Cmax) — 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 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 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 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.