PMS-URSODIOL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

URSODIOL

Доступна з:

PHARMASCIENCE INC

Код атс:

A05AA02

ІПН (Міжнародна Ім'я):

URSODEOXYCHOLIC ACID

Дозування:

250MG

Фармацевтична форма:

TABLET

Склад:

URSODIOL 250MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

CHOLELITHOLYTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2006-09-01

Характеристики продукта

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)
---
---
-