Category: Clinical Pharmacology
Purpose: The aim of the study was to evaluate drug-drug interaction between teneligliptin and atorvastatin in healthy male adults.
Methods: A randomized, open-label, three-period, six-sequence, cross-over, multiple-dose study was conducted. Subjects received teneligliptin 20 mg, atorvastatin 40 mg, or both once daily for 6 days with a 7-day wash-out period between the treatments. Blood samples for pharmacokinetic analysis were collected for 24 h after the last dose. Maximum concentration at steady state (Cmax,ss) and area under the concentration-time curve for a dosing interval at steady state (AUCτ,ss) were calculated using noncompartmental method.
Results: A total of 27 subjects completed the study and there was no treatment related adverse event. For teneligliptin, geometric mean ratios and their 90% confidence interval of co-administration to teneligliptin alone for Cmax,ss and AUCτ,ss were 1.163 (1.081 – 1.252) and 1.088 (1.044 – 1.133), respectively. For atorvastatin, those of co-administration to atorvastatin alone for Cmax,ss and AUCτ,ss were 0.797 (0.682 – 0.932) and 0.898 (0.813 – 0.992), respectively.
Conclusion: Co-administration of teneligliptin and atorvastatin were well tolerated in healthy subjects. Total systemic exposures of teneligliptin and atorvastatin were not significantly different when administered alone or in combination.