Evaluation of drug interactions of saxagliptin with sildenafil in healthy volunteers.

ABSTRACT:

Purpose

The purpose of this study is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of saxagliptin.

Methods

Eighteen healthy volunteers were recruited in sequential; single-center study to determine pharmacokinetic parameters of saxagliptin and sildenafil, and (AUC_0-∞), (AUC_0-t); C_max; t_max; t_½, k_e; k_a were measured using validated LC-MS/MS method. Therapeutic doses were given as follows: Sildenafil 50 mg single dose on day one, then washout period from day two till day eight. Saxagliptin 5 mg once/day was given from day 9 till day 12; then on day 13, the two drugs were co-administered. Blood samples for pharmacokinetic analysis were colle

SUBMITTER: Mansour RY 

PROVIDER: S-EPMC9549831 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature