A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.
- Registration Number
- NCT04084197
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- Age 19~45 years in healthy male volunteers
- BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria
- 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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 HIP1801 Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801 Sequence 2 HIP1402 Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402 Sequence 3 HIP1402 High fat diet + HIP1402, Period 2 : High fat diet + HIP1801 Sequence 2 HIP1801 Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402 Sequence 4 HIP1402 High fat diet + HIP1801, Period 2 : High fat diet + HIP1402 Sequence 3 HIP1801 High fat diet + HIP1402, Period 2 : High fat diet + HIP1801 Sequence 1 HIP1402 Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801 Sequence 4 HIP1801 High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
- Primary Outcome Measures
Name Time Method Cmax of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
AUClast of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method AUCinf of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Tmax of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
t1/2 of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
CL/F of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Vd/F of Tamsulosin pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of