A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects
A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults
1 other identifier
interventional
31
1 country
1
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2018
Shorter than P25 for phase_1
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
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedFirst Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedSeptember 12, 2019
September 1, 2019
1 month
September 5, 2019
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of Vildagliptin
pharmacokinetic evaluation
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
AUClast of Vildagliptin
pharmacokinetic evaluation
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary Outcomes (5)
AUCinf of Vildagliptin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Tmax of Vildagliptin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
t1/2 of Vildagliptin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
CL/F of Vildagliptin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Vd/F of Vildagliptin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Study Arms (2)
Sequence 1
EXPERIMENTALPeriod 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809
Sequence 2
EXPERIMENTALPeriod 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~55 years in healthy volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 24.9 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
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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System, Severance Hospital
Seoul, 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
September 5, 2019
First Posted
September 12, 2019
Study Start
October 23, 2018
Primary Completion
November 27, 2018
Study Completion
November 27, 2018
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share