Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2021-11-03

Brief Summary

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A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

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Detailed Description

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A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Conditions

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Healthy Volunteer

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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Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1

Period 1: RLD2104 Period 2: HIP2105

Group Type EXPERIMENTAL

HIP2105

Intervention Type DRUG

Test drug

RLD2104

Intervention Type DRUG

Reference drug

Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2

Period 1: HIP2105 Period 2: RLD2104

Group Type EXPERIMENTAL

HIP2105

Intervention Type DRUG

Test drug

RLD2104

Intervention Type DRUG

Reference drug

Interventions

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HIP2105

Test drug

Intervention Type DRUG

RLD2104

Reference drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria

* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
* Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
* Heavy smoker (\>10 cigarettes/day).

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes