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

NCT03220867 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-02-28

No results posted yet for this study

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

Interventions

DRUG

Risperidone: Xian Risperdal (test)

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

DRUG

Risperidone: Gurabo Risperdal (reference)

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

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2018-01-02
Completion
2018-04-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220867 on ClinicalTrials.gov