Overview

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

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Treatments:
Bepotastine besilate
Erdosteine
Criteria
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