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

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).

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naftopidil

Drug

25mg/ 50 mg/ 75mg dosage tablets

Primary outcomes

Pharmacokinetics of naftopidil

Time frame: Dec. 2009 (anticipated)

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Aug 28, 2009
Registry last updated: Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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