Guangzhou Diqi Pharmaceutical Technology Co., Ltd

The main test objective is to use the phloroglucinol freeze-dried tablets (160 mg) certified by Teva Sante as the reference preparation and the phloroglucinol orally disintegrating tablets (160 mg) produced by Guangzhou Diqi Pharmaceutical Technology Co., Ltd. as the test preparation, and evaluate the bioequivalence of the two preparations in the human body under the fed state through a single-center, randomized, open, single-dose, two-preparation, two-cycle, double-crossover study. Secondary test objective: Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

① Obtain the pharmacokinetic parameters and release characteristics of the active ingredients (risperidone + 9-hydroxyrisperidone) of LPT14E2 after a single dose in humans for the first time. The dose range of this study does not exceed the upper limit of the approved clinical dose of RISPERDAL CONSTA®. ② Evaluate the safety and tolerability of LPT14E2 at each study dose. ③ Compare the PK with the single dose of RISPERDAL CONSTA® at 25 mg to prove the corresponding relationship between the dose of LPT14E2 and RISPERDAL CONSTA®. ④ Prove that LPT14E2 has linear PK in the dose range of 50~100 mg.

Using the certified phloroglucinol lyophilized tablets (160 mg) produced by Teva Sante as the reference preparation, and the phloroglucinol orodisintegrating tablets (160 mg) produced by Guangzhou Diqi Pharmaceutical Technology Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-period, double-crossover study was performed to evaluate the bioequivalence of the two preparations in humans under fasting and fed conditions.