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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 October 19, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors