Recruiting

4

190

 

IM ziprasidone ;Ziprasidone Hydrochloride Capsules

Beijing Hui Long Guan Hospital; Beijing Hui Long Guan Hospital, Pfizer

schizophrenia

 

 

Not yet recruiting

1

30

 

Screened volunteers were randomized to receive T-R sequential dosing, according to a randomization table, with a single intramuscular injection of either the test formulation [ T, 30 mg (as ziprasidone), 441 mg (sulfobutyl betacyclodextrin sodium) per vial per cycle in the fasting state; manufactured by Nanjing Zhengda Tianqing Pharmaceutical Co. Ltd.), both at a dose of 10 mg (formulated at 20 mg/mL [as ziprasidone], 0.5 mL intramuscularly), administered once per cycle with a washout period of at least 4 days between dosing cycles. In the second cycle, volunteers were administered another formulation intramuscularly according to the study protocol, and the procedure was repeated in the first cycle with an exit test. The first cycle procedure was repeated and the group was checked. ;Screened volunteers were randomized to receive R-T sequential dosing, and according to a randomization table, volunteers received a single intramuscular injection of the reference formulation per cycle in the fasting state [ R, containing 30 mg (as ziprasidone) per vial, 441 mg (sodium sulfobutyl betacyclodextrin)], all administered at a dose of 10 mg (formulated at 20 mg/mL [as ziprasidone], 0.5 mL intramuscularly), once per cycle, with a washout period of at least 4 days between dosing cycles. Cycle 2: Volunteers were all administered another formulation intramuscularly according to the study protocol, respectively, and the cycle 1 procedure was repeated with an outgroup examination.

Clinical Trial Center of Third Xiangya Hospital of Central South University; Third Xiangya Hospital, Central South University, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.

N/A