Status:
COMPLETED
The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assig...
Eligibility Criteria
Inclusion
- Healthy males subjects, 20-45 years inclusive
- Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive
- Written informed consent given
Exclusion
- Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil
- History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology
- Have a history of drug abuse, or show positive for drug abuse at urine screening
- Have participated in another clinical study within 2 months prior to entering inth the study
- Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00967772
Start Date
September 1 2009
End Date
March 1 2010
Last Update
October 1 2014
Active Locations (1)
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1
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul, South Korea