Experiment 397325
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Serenoa repens (ARECACEAE) |
| Citation | BOMBARDELLI,E: MORAZZONI,P:. (1997). SERENOA REPENS (BARTRAM) J.K. SMALL.. 68(2) |
| Amount utilized | |
| Compound isolated | |
| Disease | THE PHARMACOKINETICS OF S. REPENS EXTRACT HAVE BEEN INVESTIGATED IN MEN, IN A STUDY OF BIOEQUIVALENCE OF A NEW ORAL FORMULATION (320 MG CAPSULES) IN COMPARISON TO A REFERENCE PREPARATION (160MG). THIS OPEN, SINGLE DOSE, RANDOMISED, TWO PERIOD CROSS-OVER STUDY WAS CARRIED OUT ON 12 HEALTHLY MALE SUBJECTS WHO RECEIVED BY MOUTH 1X320 MG CAPSULE OF S. REPSNS (NEW FORMUALTION) OR 2X160 MG CAPSULES (REFERENCE PREPARATION). THE S. REPENS EXTRACT WAS RAPIDLY ABOSRBED WITH A PEAK TIME (TMAX) OF 1.50-1.58H AND PEAK PLASMA LEVELS (CMAX) OF 2.54-2.67 UG/ML. THE AREA UNDER CURVE VALUE (AUC) RANGED FROM 7.99 TO 8.42 UG.H/ML. THE PLASMA CONCENTRATION-TIME PROFILE OF BOTH PREPARATIONS WAS NEALRY IDENTICAL. THE BIOEQUIVALENCE ANALYSIS OF PHARMACOKINETIC PARAMETERS SHOWED THAT THE TWO PREPARATIONS CAN BE CONSIDERED AS BIOEQUIVALENT. |
| Dose amount | 320.0 MG |
| Number | 3 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Dose expression | DOSE |
| Extract | HEXANE EXT |
| Gender | GIVEN TO BOTH SEXES |