[Translation] A 12-week single-center, open-label, controlled design, low-, medium-, and high-dose single-dose sequential ramping pharmacokinetic study to evaluate the pharmacokinetics of LPT14E2 in patients with stable schizophrenia. Clinical study of biological parameters and tolerability characteristics
①首次在人体获得LPT14E2单次给药后活性成分(利培酮+9-羟利培酮)的药代动力学参数和释放特征,本研究的剂量范围不超过相当于RISPERDAL CONSTA®已获批的临床使用剂量上限。②评价各研究剂量下LPT14E2的安全性和耐受性。③与RISPERDAL CONSTA®单剂量25 mg的PK比较,证明LPT14E2与RISPERDAL CONSTA®的剂量的对应关系。④证明LPT14E2在50~100 mg剂量范围内呈线性PK。
[Translation] ① It is the first time to obtain the pharmacokinetic parameters and release characteristics of the active ingredients (risperidone + 9-hydroxyrisperidone) after a single dose of LPT14E2 in humans. The dose range of this study does not exceed the equivalent of RISPERDAL CONSTA®, which has been approved The upper dose limit for clinical use. ②Evaluate the safety and tolerability of LPT14E2 at each study dose. ③Compared with the PK of RISPERDAL CONSTA® single dose 25 mg, proving the dose-corresponding relationship between LPT14E2 and RISPERDAL CONSTA®. ④ Prove that LPT14E2 exhibits linear PK within the dose range of 50~100 mg.