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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967772
First Posted: August 28, 2009
Last Update Posted: October 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
  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: Intervention Model: Parallel Assignment
Masking: Single (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 ST Co., Ltd.:

Primary Outcome Measures:
  • Pharmacokinetics of naftopidil [ Time Frame: Dec. 2009 (anticipated) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967772


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

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT00967772     History of Changes
Other Study ID Numbers: FLV100
First Submitted: August 26, 2009
First Posted: August 28, 2009
Last Update Posted: October 1, 2014
Last Verified: September 2014

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

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