A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- HGP1607
- Conditions
- Healthy Male Volunteers
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- AUClast of HGP1607
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.age 19\~40 years
- •2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
- •3.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
Seguence 3
Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Intervention: HGP1607
Seguence 3
Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Intervention: HGP1501
Seguence 3
Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Intervention: HGP1607+HGP1501
Seguence 1
Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Intervention: HGP1607
Seguence 1
Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Intervention: HGP1501
Seguence 1
Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Intervention: HGP1607+HGP1501
Seguence 2
Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Intervention: HGP1607
Seguence 2
Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Intervention: HGP1501
Seguence 2
Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Intervention: HGP1607+HGP1501
Seguence 4
Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Intervention: HGP1607
Seguence 4
Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Intervention: HGP1501
Seguence 4
Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Intervention: HGP1607+HGP1501
Seguence 5
Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Intervention: HGP1607
Seguence 5
Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Intervention: HGP1501
Seguence 5
Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Intervention: HGP1607+HGP1501
Seguence 6
Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607
Intervention: HGP1607
Seguence 6
Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607
Intervention: HGP1501
Seguence 6
Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607
Intervention: HGP1607+HGP1501
Outcomes
Primary Outcomes
AUClast of HGP1607
Time Frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP1607
Time Frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP1501
Time Frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP1501
Time Frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary Outcomes
- AUCinf of HGP1607(16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h)
- Tmax of HGP1607(16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h)
- T1/2 of HGP1607(16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h)
- AUClast of HGP1501(0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h)
- Cmax of HGP1501(0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h)
- baseline corrected AUCinf of HGP1501(0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h)
- baseline corrected Tmax of HGP1501(0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h)
- baseline corrected T1/2 of HGP1501(0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h)