Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
URSODIOL
PHARMASCIENCE INC
A05AA02
URSODEOXYCHOLIC ACID
250MG
TABLET
URSODIOL 250MG
ORAL
100
Prescription
CHOLELITHOLYTIC AGENTS
Active ingredient group (AIG) number: 0122789001; AHFS:
APPROVED
2006-09-01
PRODUCT MONOGRAPH pms-URSODIOL Ursodiol Tablets USP 250mg LITHOLYTIC AGENT PHARMASCIENCE INC. DATE OF PREPARATION: 6111 Royalmount Avenue, Suite 100 August 29, 2006 Montreal, Quebec H4P 2T4 Control No. 087654 - 2 - PRODUCT MONOGRAPH pms-URSODIOL Ursodiol Tabalets USP 250mg THERAPEUTIC CLASSIFICATION Litholytic agent ACTION AND CLINICAL PHARMACOLOGY Ursodiol, a naturally occurring bile acid, is present as a minor fraction of the total human bile acids. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid. Since in patients with gallstones, the total bile acid pool size is generally reduced, the exogenous supply of ursodiol helps to increase this bile acid pool size and increases the cholesterol saturation index. In addition, the fecal bile acid loss is increased and cholesterol secretion into the bile is reduced, without a concomitant reduction in phospholipids. Consequently, the cholesterol saturation of bile is reduced, allowing gradual solubilization of cholesterol from gallstones to occur. Single-Dose Crossover Comparative Bioavailability Study of pms-URSODIOL 2 x 250 mg Tablets, Lot # NB070-93, Mfr. Date January 21, 2003, was performed _versus_ Axcan Pharma Inc., URSO 2 x 250 mg Tablets, Lot # FN47, Exp. Date September 2004, Administered as 2 x 250 mg Tablet in Healthy Subjects Under Fasting Conditions. Bioavailability data were measured and the results are summarized in the following table: - 3 - SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA URSODIOL (2 X 250 mg) From measured ursodiol data (corrected for baseline) Geometric Mean Arithmetic Mean (CV %) Parameter Test pms-URSODIOL Reference URSO®† % Ratio of Geometric Means 90% Confidence Interval LOWER UPPER AUC T (ng.h/mL) 13073.3 13662.1 (31.9) 13552.5 14934.3 (51.7) 96.46 83.30 111.71 AUC I (ng.h/mL) 14061.8 15036.8 (34.2) 12871.9 14120.3 (37.0) 109.24 94.20 126.69 C MAX (ng/mL) 3299.5 3393.3 (25.3) 3440.2 3597.5 (29.1) 95.91 83.53 110.12 T MAX * (h) 2.00 (66.2) 2.50 (98.6) --- --- - Կարդացեք ամբողջական փաստաթուղթը