Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers
Last updated on April 2022Recruitment
- 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
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