Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
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.
Inclusion Criteria:

 1. Subjects willing to adhere to the protocol requirements and to provide written
 informed consent.

 2. Subjects aged between 45 and 65 years，healthy male and non-pregnant, non breast
 feeding female.

 3. Subjects' weight within clinically acceptable normal range according to normal values
 for Body Mass Index (19.00 to 26.00 kg/m2) with minimum of 50 kg weight for male, and
 minimum of 45 kg weight for female.

 4. No medical history of significant cardiovascular, pulmonary, hepatic, renal,
 gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital
 or psychiatric disease or disorder.

 Exclusion Criteria:

 -  1)Subjects with family history of muscular dystonia or the subject has had the drug
 source dystonia.

 2）Subject with history of a asthma. 3）Subject with any (acute or chronic) history of
 mental illness or have family history of mental illness.

 4）Subject have alzheimer's or alzheimer's disease. 5）Subject was hospitalized within
 60 days prior to the first dose of the study drug 6）Subject smoking more than five
 cigarettes within 1 month prior to the first dose study drug.

 7）History or presence of significant easy bruising or bleeding 8）History or presence
 of drug abuse. 9）History of allergic reactions. 10）History or presence of taking
 psychotropic drugs。 11）Subjects having positive urine screen for drugs of abuse
 including Methamphetamine, MDMA, ketamine, morphine, heroin.

 12）Any treatment which could bring about induction or inhibition of hepatic microsomal
 enzyme system within 3 weeks prior to Period 01 dosing.

 13）Consumption of hypericum perforatum containing products and grapefruit or
 grapefruit juice from 72 hours prior admission to 3 days after trail end.

 14）Subject involved other clinical trials of drugs within 3 months prior to period 01
 dosing.

 15）Subject with abnormal laboratory tests and diagnosed by physicians as clinically
 significant 17）Abnormal vital signs test for any one or more:

 Abnormal blood pressure:

 -  Systolic pressure is lower than 80mmHg and/or diastolic pressure down to 40mmHg in
 sitting position.

 -  Systolic pressure is higher than 140mmHg and/or diastolic pressure higher than 90mmHg
 in sitting position.

 Abnormal cardiac rate:

 -  cardiac rate lower than 50

 -  cardiac rate higher than 50 18）Blood alcohol test values≥10mg/dL 19）Volunteer who have
 donated blood components within 2 weeks prior to the first dose or donated blood (more
 than 200 ml within 4 weeks; more than 400 ml within 60 days) prior to the first dose;
 Volunteer who plan to donate blood during the study or 4 weeks after study; Volunteer
 who lost blood (more than 50ml within 7days or more than 400ml within 30 days) for
 surgery.

 20）Subjects not willing to follow approved birth control methods for the duration of
 the study 21）ubjects having positive Serum β-hCG test. 22）Subjects plan to donate
 sperm during study period or 30 days after study 23）Hamilton depression Rating Scale (
 17 ) score above 7 points. 24）History of blood phobia. Subjects whom the investigator
 deems necessary to exclude.