Clinical trial NCT03220867: Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Two-Period, Two-Cohort, Crossover Study to Assess the Bioequivalence of Xian Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Subjects Compared With Gurabo Risperdal Tablets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions.


Eligibility criteria: Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study and adhere to the prohibitions and restrictions specified in this protocol
* 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:

* Presence of orthostatic hypertension at screening, defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg compared to supine position when the participant assumes a standing position
* 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose
measure: Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last])
timeFrame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to approximately 29 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: