Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: Risperidone: Xian Risperdal (test); Drug: Risperidone: Gurabo Risperdal (reference)

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100036
    • Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Risperidone: Xian Risperdal (test); Participants will receive 1*1 mg tablet of Xian Risperdal under fasting or fed condition.; Other Names: JNJ-410397-AAA; Drug: Risperidone: Gurabo Risperdal (reference); Participants will receive 1*1 mg tablet of Gurabo Risperdal under fasting or fed condition.
Experimental: 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.	Drug: Risperidone: Xian Risperdal (test); Participants will receive 1*1 mg tablet of Xian Risperdal under fasting or fed condition.; Other Names: JNJ-410397-AAA; Drug: Risperidone: Gurabo Risperdal (reference); Participants will receive 1*1 mg tablet of Gurabo Risperdal under fasting or fed condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentration (Cmax) will be assessed.	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
Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last])	Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.	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
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to approximately 29 days

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): January 2, 2018
• Study Completion (Anticipated): April 27, 2018

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

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; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR108341; R064766SCH1013 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China)

Drug and device information, study documents

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