An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- HIP1402
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Cmax of Tamsulosin
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sequence 1
Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
Intervention: HIP1402
Sequence 1
Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
Intervention: HIP1801
Sequence 2
Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
Intervention: HIP1402
Sequence 2
Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
Intervention: HIP1801
Sequence 3
High fat diet + HIP1402, Period 2 : High fat diet + HIP1801
Intervention: HIP1402
Sequence 3
High fat diet + HIP1402, Period 2 : High fat diet + HIP1801
Intervention: HIP1801
Sequence 4
High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
Intervention: HIP1402
Sequence 4
High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
Intervention: HIP1801
Outcomes
Primary Outcomes
Cmax of Tamsulosin
Time Frame: 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
Time Frame: pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
Secondary Outcomes
- AUCinf of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- Tmax of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- 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)
- 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)
- 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)