A Randomized, Open-label, Oral Single Dose, Two-way Crossover Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability After Administration of HCP1401 and Co-administration of HCP0605 and HGP1405 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- HCP0605
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- AUClast
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers
Detailed Description
The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteer, age 19\~45 years
- •Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- •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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •Subjects who judged ineligible by the investigator.
Arms & Interventions
Sequence A
Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Intervention: HCP0605
Sequence A
Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Intervention: HGP1405
Sequence A
Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Intervention: HCP1401
Sequence B
Period 1 : HCP1401 Period 2 : HCP0605+HGP1405
Intervention: HCP0605
Sequence B
Period 1 : HCP1401 Period 2 : HCP0605+HGP1405
Intervention: HGP1405
Sequence B
Period 1 : HCP1401 Period 2 : HCP0605+HGP1405
Intervention: HCP1401
Outcomes
Primary Outcomes
AUClast
Time Frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Area under the plasma concentration versus time curve
Cmax
Time Frame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Peak Plasma Concentration
Secondary Outcomes
- AUCinf(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- T1/2(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Cl/F(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Vz/F(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Tmax(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)