BioequivalenceNCT03232710
Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
A study testing Bosiqing and abilify in people with Bioequivalence, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Bosiqing and abilify
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Xiang Jin, 11679295@qq.com
About this study
Official title: 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.
- Conditions
- Bioequivalence
- Being tested
- Bosiqing, abilify
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosiqingDrug
Aripiprazole Orally disintegrating tablets 10mg
abilifyDrug
Aripiprazol orodispersible tablets 10mg
| Study group | Role | What they receive |
|---|---|---|
| pilot study group | Experimental | Not described Receives: Drug: abilify |
| group 1 (under fasting condition) | Experimental | Not described Receives: Drug: Bosiqing; Drug: abilify |
| group 2 (under fasting condition) | Experimental | Not described Receives: Drug: Bosiqing; Drug: abilify |
| group 3 (under fed condition) | Experimental | Not described Receives: Drug: Bosiqing; Drug: abilify |
| group 4 (under fed condition) | Experimental | Not described Receives: Drug: Bosiqing; Drug: abilify |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: Cmax
Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition
Measured: day 54
Pharmacokinetic parameter: AUC
Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition
Measured: day 54
Secondary outcomes (1)
Adverse Events
To observe the type, incidence and severity of adverse events in the study.
Measured: up to day 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start26 Jun 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232710
- Sponsor's protocol ID
- KH716-E01-CRP-1.1
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03232710
- Acronym / sponsor ID
- KH716-E01-CRP-1.1
- Conditions
- Bioequivalence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| pilot study group | Experimental | Drug: abilify |
| group 1 (under fasting condition) | Experimental | Drug: Bosiqing, Drug: abilify |
| group 2 (under fasting condition) | Experimental | Drug: Bosiqing, Drug: abilify |
| group 3 (under fed condition) | Experimental | Drug: Bosiqing, Drug: abilify |
| group 4 (under fed condition) | Experimental | Drug: Bosiqing, Drug: abilify |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosiqingAripiprazole Orally disintegrating tablets 10mg | Drug | group 1 (under fasting condition), group 2 (under fasting condition), group 3 (under fed condition), group 4 (under fed condition) |
| abilifyAripiprazol orodispersible tablets 10mg | Drug | group 1 (under fasting condition), group 2 (under fasting condition), group 3 (under fed condition), group 4 (under fed condition), pilot study group |
Primary outcome
Pharmacokinetic parameter: Cmax
Time frame: day 54
Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition
Pharmacokinetic parameter: AUC
Time frame: day 54
Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition
1 secondary outcome
Adverse Events
Time frame: up to day 54
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bosiqing and abilify in people with Bioequivalence, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Jin (+83-13880932568, 11679295@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter: Cmax (time frame: day 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.