The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
- Registration Number
- NCT00967772
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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 assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naftopidil Naftopidil -
- Primary Outcome Measures
Name Time Method Pharmacokinetics of naftopidil Dec. 2009 (anticipated)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of