MINT-TRIMEBUTINE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TRIMEBUTINE MALEATE

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

A03AA05

INN (Internationale Bezeichnung):

TRIMEBUTINE

Dosierung:

200MG

Darreichungsform:

TABLET

Zusammensetzung:

TRIMEBUTINE MALEATE 200MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0115865004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-05-26

Fachinformation

PRODUCT MONOGRAPH
PR
MINT-TRIMEBUTINE
TRIMEBUTINE MALEATE TABLETS
100 MG AND 200 MG
LOWER GASTROINTESTINAL TRACT MOTILITY REGULATOR
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
DATE OF PREPARATION:
May 18, 2023
CONTROL NUMBER: 248090
MINT-TRIMEBUTINE Product Monograph
Page 2 of 20
PRODUCT MONOGRAPH
Pr
MINT-TRIMEBUTINE
Trimebutine Maleate Tablets
100 mg and 200 mg
THERAPEUTIC CLASSIFICATION
Lower gastrointestinal tract motility regulator
CLINICAL PHARMACOLOGY
MINT-TRIMEBUTINE (trimebutine maleate) is a noncompetitive spasmolytic
agent. It possesses
moderate opiate receptor affinity and has marked anti-serotonin
activity especially on 'M'
receptors. It induces regulation of spontaneous activity and increases
synchronization between
electrophysiological spikes and contractions in isolated guinea pig
strips of colon and ileum.
However, it does not alter normal motility, but regulates abnormal
intestinal activity.
COMPARATIVE BIOAVAILABILITY STUDIES
A double blind, balanced, randomized, two-way crossover bioequivalence
study of a 1 × 200 mg
oral dose of MINT-TRIMEBUTINE (trimebutine maleate) Tablets, 200 mg
(Mint Pharmaceuticals
Inc.) and TRIMEBUTINE (trimebutine maleate) Tablets, 200 mg (AA PHARMA
INC.) was
conducted in 28 healthy adult Asian male subjects under fasting
conditions. The results of the
27 subjects who completed the study are summarized in the table below.
MINT-TRIMEBUTINE Product Monograph
Page 3 of 20
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
Trimebutine
(1 x 200 mg)
From measured data
Geometric Mean
Arithmetic Mean (CV %)
Parameter
Test
1
Reference
2
% Ratio of
Geometric Means
90% Confidence
Interval
AUC
T
(ng•hr/mL)
369.59
429.35 (54.17)
344.36
411.28 (63.66)
107.3
(96.6 - 119.3)
AUC
I
(ng•hr/mL)
405.10
466.95 (52.99)
368.09
436.82 (62.28)
110.1
(99.3 - 122.0)
C
max
(ng/mL)
263.28
305.16 (49.67)
242.03
280.49 (52.16)
108.8
(93.2 - 126.9)
T
max
3
(h)
0.67 (0.33 - 1.50)
0.83 (0.50 - 2.00)
T
1/2
4
(h)
19.62 (77.88)
12.75 (35.95)
1
Mint-Trimebutine (trimebuti