MedTrace Logo

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

NCT03196531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-05-13

No results posted yet for this study

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

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.

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
2017-11-07
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • China

Study Locations

More Related Trials

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 NCT03196531 on ClinicalTrials.gov