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The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00967772
First received: August 26, 2009
Last updated: April 22, 2010
Last verified: April 2010
History of Changes

August 26, 2009
April 22, 2010
September 2009
October 2009   (final data collection date for primary outcome measure)
Pharmacokinetics of naftopidil [ Time Frame: Dec. 2009 (anticipated) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967772 on ClinicalTrials.gov Archive Site
Not Provided
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The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers

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).
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
Drug: Naftopidil
25mg/ 50 mg/ 75mg dosage tablets
Experimental: Naftopidil
Intervention: Drug: Naftopidil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2010
October 2009   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00967772
FLV100
No
Seon-Ho, Shin. MR., Study Manager, Product Development & Licensing Div. Dong-A Pharmaceutical Co.,Ltd.
Dong-A Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Kyung-Sang Yu, M.D.,Ph.D. Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital
Dong-A Pharmaceutical Co., Ltd.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP