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

A Randomized, Open-label, Single Dose, Three-treatment, Three-period, Six-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Erdosteine and Bepotastine Besilate After Oral Administration in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Erdos; Drug: Talion; Drug: Erdos, Talion

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erdosteine 300mg	Drug: Erdos; capsule, 300mg
Experimental: Bepotastine besilate 10mg	Drug: Talion; tablet, 10mg
Experimental: Erdosteine 300mg + Bepotastine besilate 10mg	Drug: Erdos, Talion; capsule 300mg and tablet 10mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 4, 2015
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 4, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Allergic Agents; Bepotastine besilate
• Other Study ID Numbers: DW_DWJ1340001