Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition

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

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 Overview

• Status: Unknown
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: abilify; Drug: Bosiqing

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Jin; Phone Number: +83-13880932568; Email: 11679295@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Xiang Jin; Email: 11679295@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: KH716-E01-CRP-1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No