NCT00967772

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

August 26, 2009

Last Update Submit

September 30, 2014

Conditions

Healthy

Keywords

PharmacokineticsSafetytolerability

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of naftopidil

    Dec. 2009 (anticipated)

Study Arms (1)

Naftopidil

EXPERIMENTAL
Drug: Naftopidil

Interventions

NaftopidilDRUG

25mg/ 50 mg/ 75mg dosage tablets

Naftopidil

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial center, Clinical Research institute, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

naftopidil

Study Officials

  • Kyung-Sang Yu, M.D.,Ph.D.

    Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 28, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2009

Study Completion

March 1, 2010

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

KR(1)