Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Inclusion criteria

• Healthy subject older than 19 years men at the screening
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
• Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
• Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

• BMI = Weight(kg)/ Height(m)2
• Individuals who had agreed to participate in the study
• Individuals without mental illness history within five year prior to the screening
• Individuals without a medical history of gastrointestinal operations that may affect drug absorption
• Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration

Exclusion criteria

• Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
• Individuals who had excessive drinking within the 1 month

*Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)

• Individuals who had taken any medication within 10 days prior to the first day of dosing
• Individuals who were deemed to be inappropriate to participate in the study by the investigator
• Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
• Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
• Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
• Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
• Individuals with orthostatic hypotension
• Individuals with severe hepatopathy
• Individuals who had taken alpha-1 blocker
• Individuals who had history of micturition syncope
• Individuals with nephropathy
• Elderly person
• Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
• Individuals who had taken CYP3A4 inhibitor
• Individuals who had taken antihypertensive drug(s)