A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2018-11-27

Brief Summary

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

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Detailed Description

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Conditions

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Health, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809

Group Type EXPERIMENTAL

HIP1701

Intervention Type DRUG

Vildagliptin

HGP1809

Intervention Type DRUG

Vildagliptin

Sequence 2

Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701

Group Type EXPERIMENTAL

HIP1701

Intervention Type DRUG

Vildagliptin

HGP1809

Intervention Type DRUG

Vildagliptin

Interventions

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HIP1701

Vildagliptin

Intervention Type DRUG

HGP1809

Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes