Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants
NCT ID: NCT03220867
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2017-12-11
2018-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment Sequence: AB
Participants in cohort 1 (fasting) and cohort 2 (fed) will receive 1 milligram (mg) risperidone administered as Xian Risperdal (test) 1\*1 mg oral tablet (Treatment A) on Day 1 in Period 1 followed by 1 mg risperidone administered as Gurabo Risperdal (reference) 1\*1 mg oral tablet (Treatment B) on Day 1 in period 2. There will be a washout period of at least 10 days between treatments.
Risperidone: Xian Risperdal (test)
Participants will receive 1\*1 mg tablet of Xian Risperdal under fasting or fed condition.
Risperidone: Gurabo Risperdal (reference)
Participants will receive 1\*1 mg tablet of Gurabo Risperdal under fasting or fed condition.
Treatment Sequence: BA
Participants in cohort 1 (fasting) and cohort 2 (fed) will receive Treatment B on Day 1 in period 1 followed by Treatment A on Day 1 in period 2. There will be a washout period of at least 10 days between treatments.
Risperidone: Xian Risperdal (test)
Participants will receive 1\*1 mg tablet of Xian Risperdal under fasting or fed condition.
Risperidone: Gurabo Risperdal (reference)
Participants will receive 1\*1 mg tablet of Gurabo Risperdal under fasting or fed condition.
Interventions
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Risperidone: Xian Risperdal (test)
Participants will receive 1\*1 mg tablet of Xian Risperdal under fasting or fed condition.
Risperidone: Gurabo Risperdal (reference)
Participants will receive 1\*1 mg tablet of Gurabo Risperdal under fasting or fed condition.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If a woman, must have a negative serum pregnancy test at screening and on Day -1 of each treatment period
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
* Body mass index (BMI), weight (kilogram \[kg\])/height\^2 (meter \[m\]\^2) between 19.0 and 28.0 kg/m\^2, inclusive; body weight not less than 50 kg
* After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive; diastolic blood pressure between 60 and 90 mmHg, inclusive; heart rate between 50 and 100 beats per minute (bpm), inclusive
Exclusion Criteria
* Positive test for drug screening, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates on Day -1 of each treatment period
* Drug abusers or use of soft drugs (example \[eg\], cannabis) within 3 months prior to the study or hard drugs (eg cocaine, benzene cyclohexylidene, etc.) within 1 year prior to the study
* Received an experimental drug or used an experimental medical device within 3 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
* Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test
18 Years
55 Years
ALL
Yes
Sponsors
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Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Role: STUDY_DIRECTOR
Xian-Janssen Pharmaceutical Ltd.
Locations
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Beijing Shijitan Hospital
Beijing, , China
Countries
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Other Identifiers
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R064766SCH1013
Identifier Type: OTHER
Identifier Source: secondary_id
CR108341
Identifier Type: -
Identifier Source: org_study_id