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

NCT03220867 | Withdrawn Phase 1

• 2 other identifiers: CR108341R064766SCH1013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to approximately 29 days

Study Arms (2)

Treatment Sequence: AB

EXPERIMENTAL

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); Drug: Risperidone: Gurabo Risperdal (reference)

Treatment Sequence: BA

EXPERIMENTAL

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); Drug: Risperidone: Gurabo Risperdal (reference)

Interventions

Risperidone: Xian Risperdal (test) DRUG

Participants will receive 1\*1 mg tablet of Xian Risperdal under fasting or fed condition.

Also known as: JNJ-410397-AAA

Treatment Sequence: AB; Treatment Sequence: BA

Risperidone: Gurabo Risperdal (reference) DRUG

Participants will receive 1\*1 mg tablet of Gurabo Risperdal under fasting or fed condition.

Treatment Sequence: AB; Treatment Sequence: BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, 100036, China

Location

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: December 11, 2017
• Primary Completion: January 2, 2018
• Study Completion: April 27, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

CN (1)