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
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: Naftopidil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Pharmacokinetics of naftopidil [ Time Frame: Dec. 2009 (anticipated) ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naftopidil Drug: Naftopidil
25mg/ 50 mg/ 75mg dosage tablets

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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

Locations
Korea, Republic of
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, M.D.,Ph.D. Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital
  More Information

No publications provided

Responsible Party: Seon-Ho, Shin. MR., Study Manager, Product Development & Licensing Div. Dong-A Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00967772     History of Changes
Other Study ID Numbers: FLV100
Study First Received: August 26, 2009
Last Updated: April 22, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong-A Pharmaceutical Co., Ltd.:
Pharmacokinetics
Safety
tolerability

Additional relevant MeSH terms:
Naftopidil
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 22, 2014