Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition

Study Overview
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Brief Summary
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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.

Official Title
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A Single-dose, Two-treatment, Two-sequence, Two-period, Two Way Crossover Bioequivalence Study of Bosiqing Aripiprazole Orally Disintegrating Tablets and ABILIFY Under Fasting/Fed Condition

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Bosiqing
* Drug: abilify


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects willing to adhere to the protocol requirements and to provide written informed consent. Subjects aged between 45 and 65 years，healthy male and non-pregnant, non breast feeding female. 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. 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pilot study group<br> | Drug: abilify<br>* Aripiprazol orodispersible tablets 10mg<br>|
| Experimental: group 1 (under fasting condition)<br> | Drug: Bosiqing<br>* Aripiprazole Orally disintegrating tablets 10mg<br>Drug: abilify<br>* Aripiprazol orodispersible tablets 10mg<br>|
| Experimental: group 2 (under fasting condition)<br> | Drug: Bosiqing<br>* Aripiprazole Orally disintegrating tablets 10mg<br>Drug: abilify<br>* Aripiprazol orodispersible tablets 10mg<br>|
| Experimental: group 3 (under fed condition)<br> | Drug: Bosiqing<br>* Aripiprazole Orally disintegrating tablets 10mg<br>Drug: abilify<br>* Aripiprazol orodispersible tablets 10mg<br>|
| Experimental: group 4 (under fed condition)<br> | Drug: Bosiqing<br>* Aripiprazole Orally disintegrating tablets 10mg<br>Drug: abilify<br>* Aripiprazol orodispersible tablets 10mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter: Cmax | Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition | day 54 | 
| Pharmacokinetic parameter: AUC | Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition | day 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To observe the type, incidence and severity of adverse events in the study. | up to day 54 |