Recruitment

Recruitment Status
Completed

Inclusion Criteria

Healthy male subjects aged 19 - 55 years
Written informed consent after being fully informed about the study procedures
Willingness to participate during the entire study period
...
Healthy male subjects aged 19 - 55 years
Written informed consent after being fully informed about the study procedures
Willingness to participate during the entire study period
A body mass index in the range 19 - 27 kg/m2

Exclusion Criteria

Heavy drinker (>140 g/week)
Judged not eligible for study participation by investigator
Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
...
Heavy drinker (>140 g/week)
Judged not eligible for study participation by investigator
Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
Use of medication within 7 days before the first dose
Whole blood donation during 60 days before the study
History of clinically significant drug hypersensitivity

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)

Participation Requirements

Age
Between 19 years and 55 years
Gender
Only males

Inclusion Criteria

Healthy male subjects aged 19 - 55 years
Written informed consent after being fully informed about the study procedures
Willingness to participate during the entire study period
...
Healthy male subjects aged 19 - 55 years
Written informed consent after being fully informed about the study procedures
Willingness to participate during the entire study period
A body mass index in the range 19 - 27 kg/m2

Exclusion Criteria

Heavy drinker (>140 g/week)
Judged not eligible for study participation by investigator
Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
...
Heavy drinker (>140 g/week)
Judged not eligible for study participation by investigator
Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
Use of medication within 7 days before the first dose
Whole blood donation during 60 days before the study
History of clinically significant drug hypersensitivity

Tracking Information

NCT #
NCT02089399
Collaborators
Not Provided
Investigators
Not Provided