Gender effect on metformin and sitagliptin [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-03-01 14:01 (277 d 15:51 ago) – Posting: # 22818
Views: 599

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:
Thus, gender effect is not anticipated and inclusion of only male subject should not have clinical significance on outcome of study.
Divyen Shah

Complete thread:

UA Flag
 Admin contact
22,427 posts in 4,694 threads, 1,598 registered users;
19 visitors (0 registered, 19 guests [including 7 identified bots]).
Forum time: 05:53 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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