Recruitment

Recruitment Status
Completed

Inclusion Criterias

At least 18 years old and not more than 45 healthy male volunteers
Who had passed all the screening parameters
At least 18 years old and not more than 45 healthy male volunteers
Who had passed all the screening parameters

Exclusion Criterias

A history of alcohol or drug abuse within the past year
The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
Unable to tolerate vein puncture and multiple blood samplings
...
A history of alcohol or drug abuse within the past year
The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
Unable to tolerate vein puncture and multiple blood samplings
If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
A history of blood dyscrasias
Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
A clinically significant abnormal physical exam, medical history, or laboratory studies

Summary

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

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Inclusion Criterias

At least 18 years old and not more than 45 healthy male volunteers
Who had passed all the screening parameters
At least 18 years old and not more than 45 healthy male volunteers
Who had passed all the screening parameters

Exclusion Criterias

A history of alcohol or drug abuse within the past year
The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
Unable to tolerate vein puncture and multiple blood samplings
...
A history of alcohol or drug abuse within the past year
The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
Unable to tolerate vein puncture and multiple blood samplings
If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
A history of blood dyscrasias
Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
A clinically significant abnormal physical exam, medical history, or laboratory studies

Tracking Information

NCT #
NCT01858623
Collaborators
Not Provided
Investigators
Not Provided