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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00967772

Enrollment

Registered

2009-08-28

Start date

2009-09-30

Completion date

2010-03-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Safety, tolerability

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).

Interventions

DRUGNaftopidil

25mg/ 50 mg/ 75mg dosage tablets

Study design

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of naftopidil	Dec. 2009 (anticipated)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026