To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10 mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects under fasting/fed condition as well as to monitor the safety and tolerability of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
66
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGPharmacokinetic parameter: Cmax
Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition
Time frame: day 54
Pharmacokinetic parameter: AUC
Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition
Time frame: day 54
Adverse Events
To observe the type, incidence and severity of adverse events in the study.
Time frame: up to day 54
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