Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Gemigliptin and Metformin After Oral Administration in Healthy Mexican Male Subjects
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.
Consenting, eligible healthy adult subjects sequentially received either gemigliptin 50 mg
q.d., metformin 1000 mg twice a day or gemigliptin 50 mg q.d. plus metformin 1000 mg twice a
day during 3 consecutive 7 day treatment periods separated by two 5-day washout intervals, in
accordance with a randomly assigned treatment sequence. Starting on the sixth treatment
period day, participating subjects underwent safety assessments and repeated (24 hour) blood
and urine sampling for pharmacokinetic analysis. All subjects attended to a post-study visit
for final safety assessments within 8 days of study completion or early withdrawal.
Urine and plasma samples where processed to determine gemigliptin and metformin
concentrations using validated analytical methods and pharmacokinetic profiles of both
gemigliptin and metformin were obtained using a non-compartmental method; both the rate and
degree of gemigliptin and metformin absorption resulting from their concomitant
administration relative to the administration of each drug alone were assessed in search of
potential pharmacokinetic interactions, Finally, a post hoc assessment of the degree and rate
of the absorption of gemigliptin in the study population relative to those of a group of
Korean subjects participating in phase I, repeated dose gemigliptin studies was conducted.
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