Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
1 other identifier
interventional
61
1 country
1
Brief Summary
To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedJuly 31, 2019
July 1, 2019
3 months
February 23, 2016
July 29, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
Area under the curve to the last measurable concentration
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Cmax
Peak Plasma Concentration
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Secondary Outcomes (5)
AUCinf
pre-dose(0h), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Tmax
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
T1/2
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Cl/F
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Vz/F
pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Study Arms (2)
Sequence A
EXPERIMENTALPeriod 1 : HCP0605+HGP0816 Period 2 : HCP1305
Sequence B
EXPERIMENTALPeriod 1 : HCP1305 Period 2 : HCP0605+HGP0816
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
July 31, 2019
Study Start
February 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 31, 2019
Record last verified: 2019-07