Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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
...
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
History of clinically significant drug hypersensitivity
Heavy drinker (>140 g/week)
Whole blood donation during 60 days before the study

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

Exclusion Criteria

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
...
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
History of clinically significant drug hypersensitivity
Heavy drinker (>140 g/week)
Whole blood donation during 60 days before the study

Tracking Information

NCT #
NCT02089399
Collaborators
Not Provided
Investigators
Not Provided