Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Talion; Drug: Erdos, Talion; Drug: Erdos

• Registration Number: NCT02332044
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-09
• Status Verified: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-04
• Last Update Submitted: 2015-01-04
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Healthy male subjects aged 20 - 45 years
• A body mass index in the range 18.5 - 25 kg/m2
• Willingness to participate during the entire study period
• Written informed consent after being fully informed about the study procedures

Exclusion Criteria

• Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
• History of clinically significant drug hypersensitivity
• Use of medication within 7 days before the first dose
• Heavy drinker/smoker
• Whole blood donation during 60 days before the study
• Judged not eligible for study participation by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bepotastine besilate 10mg	Talion	-
Erdosteine 300mg + Bepotastine besilate 10mg	Erdos, Talion	-
Erdosteine 300mg	Erdos	-

Primary Outcome Measures

Name	Time	Method
AUClast	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Cmax	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment