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

Overview

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).

Full Title of Study: “A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2009

Interventions

  • Drug: Naftopidil
    • 25mg/ 50 mg/ 75mg dosage tablets

Arms, Groups and Cohorts

  • Experimental: Naftopidil

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics of naftopidil
    • Time Frame: Dec. 2009 (anticipated)

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dong-A ST Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kyung-Sang Yu, M.D.,Ph.D., Principal Investigator, Assistant Professor of Clinical Pharmacology, Seoul Nat’l Univ. Hospital

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