A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001610
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 24
1.Healthy male volunteer, age 19~50 years
2.Weight =55kg and =90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3.Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4.Subjects who judged ineligible by the investigator.
1.Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2.Presence of medical history or a concurrent disease that may interfere with absorption of drugs including clinically significant disorders in GI tract
3.History of relevant drug allergies(i.e Tamsulosin, other Alpha blocker, Aspirin, Antibiotics etc) or clinically significant hypersesnsitivity reaction.
4.History of relevant food allergies(i.e. peanut,milk) or clinically significant hypersensitivity reaction.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC(AUClast, AUCinf), Cmax of Tamsulosin
- Secondary Outcome Measures
Name Time Method Tmax of Tasmsulosin; t1/2 of Tasmsulosin;CL/F of Tasmsulosin; Vz/F of Tasmsulosin