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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04087525

Enrollment

Registered

2019-09-12

Start date

2018-10-23

Completion date

2018-11-27

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective

Brief summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.

Interventions

DRUGHIP1701

Vildagliptin

DRUGHGP1809

Vildagliptin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age 19\ 55 years in healthy volunteers 2. BMI is more than 18.5 kg/m\^2 , no more than 24.9 kg/m\^2 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

1. 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 2. Subjects who judged ineligible by the investigator

Design outcomes

Primary

Measure	Time frame	Description
Cmax 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	pharmacokinetic evaluation
AUClast 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	pharmacokinetic evaluation

Secondary

Measure	Time frame	Description
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026