The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
Overview
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).
Full Title of Study: “A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: October 2009
Interventions
- Drug: Naftopidil
- 25mg/ 50 mg/ 75mg dosage tablets
Arms, Groups and Cohorts
- Experimental: Naftopidil
Clinical Trial Outcome Measures
Primary Measures
- Pharmacokinetics of naftopidil
- Time Frame: Dec. 2009 (anticipated)
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Kyung-Sang Yu, M.D.,Ph.D., Principal Investigator, Assistant Professor of Clinical Pharmacology, Seoul Nat’l Univ. Hospital
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