Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-06-15

Brief Summary

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This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

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Detailed Description

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This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence Group 1

Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)

Group Type EXPERIMENTAL

HIP1601

Intervention Type DRUG

Test Drug

HGP1705

Intervention Type DRUG

Reference Drug

Sequence Group 2

Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)

Group Type EXPERIMENTAL

HIP1601

Intervention Type DRUG

Test Drug

HGP1705

Intervention Type DRUG

Reference Drug

Interventions

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HIP1601

Test Drug

Intervention Type DRUG

HGP1705

Reference Drug

Intervention Type DRUG

Other Intervention Names

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Esomeprazole (40 mg or 20 mg) Nexium(esomeprazole 40 mg or 20 mg)

Eligibility Criteria

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Inclusion Criteria

1. Age 19\~50 years in healthy male volunteers
2. BMI is more than 18 kg/m\^2 , no more than 27.0 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

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes