The pharmacokinetic-pharmacodynamic study of novel antidiabetic drug saxagliptin in chinese schizophrenia patients complicated with T2DM / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the pharmacokinetics and pharmacodynamics of saxagliptin tablets in Chinese schizophrenia patients complicated with T2DM. METHODS: Ten male schizophrenia patients complicated with T2DM were enrolled. The protocol was to afford multi-dose of 5 mg qd for 7 d. The blood samples were collected up to 12 h after the oral administration. The plasma concentrations of saxagliptin were determined by a validated HPLC-MS/MS method. The levels of blood glucose were also measured. The pharmacokinetic parameters were calculated by DAS 3.2.4 software. RESULTS: The main pharmacokinetic parameters of saxagliptin after multi-dose of 5 mg qd were as follows ρmax was (16.27 ± 9.28) μg · L-1, tmax was (1.70 ± 0.48) h, t1/2 was (3.33 ± 0.59) h, AUC0-12 was (45.19 ± 18.67) μg · h · L-1, AUC0-∞ was (49.15 ± 19.71) μg · h · L-1, respectively. No significant correlation of plasma concentration and blood glucose was observed. CONCLUSION: The main pharmacokinetic parameters of saxagliptin are in the normal range among Chinese schizophrenia patients complicated with T2DM. The clinical use of the drug is generally safe, while the control of blood glucose was not effective enough for patients with great fluctuation.