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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Erdos; Drug: Erdos, Talion; Drug: Talion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332044

DW_DWJ1340001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

Erdosteine 300mg

Experimental group

Treatment:

Drug: Erdos

Bepotastine besilate 10mg

Experimental group

Treatment:

Drug: Talion

Erdosteine 300mg + Bepotastine besilate 10mg

Experimental group

Treatment:

Drug: Erdos, Talion