NCT03196531

A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets

A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared With Clarityne Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Loratadine (Xisimin [Test Treatment])	Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.
DRUG	Loratadine (Clarityne [Reference Treatment])	Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.

Timeline

• Start date: 2017-11-07
• Primary completion: 2018-03-31
• Completion: 2018-03-31
• First posted: 2017-06-22
• Last updated: 2020-05-13

Locations

1 site across 1 country: China