Experiment 366988
Worktypes
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Serenoa repens (ARECACEAE) |
| Citation | DE BERNARDI DI VALSERRA,M: TRIPODI,AS: CONTOS,S: GERMOGLI,R:. (1994). SERENOA REPENS CAPSULES: A BIOEQUIVALENCE STUDY.. 15(1) |
| Amount utilized | |
| Compound isolated | |
| Disease | A BIOEQUIVALENCE STUDY OF A NEW SERENOA REPENS 320 MG CAPSULE FORMULATION WAS CARRIED OUT IN 12 HEALTHY MALE SUBJECTS IN ORDER TO EVALUATE PLASMA CONCENTRATION/TIME CURVE AND TO PERFORM STANDARD BIOEQUIVALENCE ANALYSIS IN COMPARISON TO A REFERENCE 16O MG PREPARATION. THIS OPEN, RANDOMIZED STUDY HAD A SINGLE-DOSE (320 MG), CROSSOVER DESIGN AND CONSISTED OF TWO TRIAL PERIODS SEPARATED BY A ONE-WEEK WASH-OUT PERIOD. THE PLASMA CONCENTRATION-TIME PROFILE OF BOTH PREPARATIONS WAS NEARLY IDENTICAL. THE RATIO OF AUC (EXTENT OF ABSORPTION) WAS 1.026 (90% - CONFIDENCE INTERVAL 0.992-1.062), THE RATIO OF CMAX (RATE OF ABSORPTION) WAS 0.982 (90%-CONFIDENCE INTERVAL 0.930-1.038), THE DIFFERENCE OF TMAX (RATE OF ABSORPTION) WAS 0 HOURS (90%-CONFIDENCE INTERVAL FROM 0 TO 0.25 HOURS. |
| Dose amount | 320.0 MG |
| Number | 1 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | DAY |
| Dose expression | DOSE |
| Extract | HEXANE EXT |
| Gender | MALE |