PMS-URSODIOL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

URSODIOL

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

A05AA02

INN (nume internaţional):

URSODEOXYCHOLIC ACID

Dozare:

250MG

Forma farmaceutică:

TABLET

Compoziție:

URSODIOL 250MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CHOLELITHOLYTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0122789001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-09-01

Caracteristicilor produsului

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
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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:
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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)
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