AG-FAMOTIDINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FAMOTIDINE

Saatavilla:

ANGITA PHARMA INC.

ATC-koodi:

A02BA03

INN (Kansainvälinen yleisnimi):

FAMOTIDINE

Annos:

40MG

Lääkemuoto:

TABLET

Koostumus:

FAMOTIDINE 40MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HISTAMINE H2-ANTAGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0118722002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-12-21

Valmisteyhteenveto

1
PRODUCT MONOGRAPH
Pr
AG-Famotidine
(Famotidine Tablets, USP)
20 mg and 40 mg
Histamine H
2
Receptor Antagonist
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
Date of Revision:
December 17, 2020
J4B 5H3
Submission Control: 246643
2
PRODUCT MONOGRAPH
Pr
AG-Famotidine
(Famotidine Tablets, USP)
20 and 40 mg
THERAPEUTIC CLASSIFICATION
Histamine H
2
Receptor Antagonist
ACTION AND CLINICAL PHARMACOLOGY
Famotidine is a competitive inhibitor of histamine H
2
receptors. The primary clinically
important pharmacologic activity of famotidine is inhibition of
gastric juice secretion.
Famotidine reduces the acid and pepsin content, as well as the volume,
of basal,
nocturnal,
and stimulated gastric secretion.
COMPARATIVE BIOAVAILABILITY STUDY
A double-blind, balanced, randomized, two-treatment, two-sequence,
two-period, single-
dose crossover oral bioequivalence study of AG-Famotidine (Famotidine)
tablets, 40 mg
(Angita Pharma Inc.) and
Pr
TEVA-FAMOTIDINE (Famotidine) tablets, 40 mg (Teva
Canada
Limited)
was
conducted
in
54
healthy,
adult,
male
subjects
under
fasting
conditions. Comparative bioavailability data from 54 subjects that
were included in the
statistical analysis are presented in the following table:
3
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
FAMOTIDINE
(1 × 40 mg)
From measured data
Geometric Mean
Arithmetic Mean (CV %)
PARAMETER
TEST
*
REFERENCE
†
% RATIO OF
GEOMETRIC
MEANS
90% CONFIDENCE
INTERVAL
AUC
T
(ng.hr/ mL)
944.84
979.42 (26.15)
915.06
955.11 (27.65)
103.3
97.3-109.6
AUC
I
(ng.hr/ mL)
971.47
1007.01 (26.14)
942.22
982.79 (27.49)
103.1
97.3-109.2
C
max
(ng/ mL)
136.85
142.25 (29.04)
131.50
136.86 (27.93)
104.1
97.7-110.8
T
max
§
(h)
2.25
(1.00- 4.00)
2.25
(1.00- 6.00)
T
½
€
(h)
4.55 (17.23)
4.65 (20.66)
*
AG-Famotidine (famotidine) tablets, 40 mg (Angita Pharma Inc.)
†
Pr
TEVA-FAMOTIDINE (famotidine) tablets, 40 mg (Teva Canada Limited)
§
Expressed as the median (range)
€
Expressed as the arithmetic mean (CV%) only
INDICATIONS AND CLINICAL USE
AG-Famotidine (famotidine) are