Gender effect on metformin and sitagliptin [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-03-01 13:01 (87 d 03:11 ago) – Posting: # 22818
Views: 409

Dear Khageswara Rao!
As per label for metformin: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender (males = 19, females = 16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of metformin hydrochloride tablets, USP was comparable in males and females.

For Sitagliptin: Based on a population pharmacokinetic analysis or a composite analysis of available pharmacokinetic data, BMI, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of sitagliptin. When the effects of age on renal function are taken into account, age alone did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis. Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Kindly find the screenshot for same:
[image]
Thus, gender effect is not anticipated and inclusion of only male subject should not have clinical significance on outcome of study.
Regards,
Divyen Shah

Complete thread:

UA Flag
Activity
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Friday 17:12 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5