An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers
Status:
Completed
Trial end date:
2016-05-03
Target enrollment:
Participant gender:
Summary
This is an open, randomized (randomization ratio: 1:1), multiple dose, three way, three
period cross over study to assess the potential for drug drug interactions between
gemigliptin (a DPP-IV inhibitor mainly metabolized by CYP3A4) and metformin in a sample of
healthy Mexican volunteers, aimed to determine whether the observed lack of drug-drug
interactions between gemigliptin and metformin in the Korean population is reproducible in an
ethnically different population characterized by a significant difference in the frequency of
CYP3A4 polymorphisms associated with decreased enzymatic activity, such as CYP3A4*1b, in
comparison with Asian populations.