The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
This study has been completed.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
First received: August 26, 2009
Last updated: September 30, 2014
Last verified: September 2014
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).
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
||A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers
Primary Outcome Measures:
- Pharmacokinetics of naftopidil [ Time Frame: Dec. 2009 (anticipated) ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
25mg/ 50 mg/ 75mg dosage tablets
|Ages Eligible for Study:
||20 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00967772
|Clinical Trial center, Clinical Research institute, Seoul National University Hospital
|Seoul, Korea, Republic of |
Dong-A ST Co., Ltd.
||Kyung-Sang Yu, M.D.,Ph.D.
||Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital
No publications provided
||Dong-A ST Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 26, 2009
||September 30, 2014
||Korea: Food and Drug Administration
Keywords provided by Dong-A ST Co., Ltd.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors