Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers
- 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
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
- Secondary Outcome Measures
Name Time Method