NCT03220867

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-12-11
• Primary completion: 2018-01-02
• Completion: 2018-04-27
• First posted: 2017-07-18
• Last updated: 2018-02-28

Locations

1 site across 1 country: China