to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-05-31

Brief Summary

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to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants

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Detailed Description

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Conditions

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Erosive Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part1_test group

IV injection of test drugs by dose group

Group Type EXPERIMENTAL

Fexuprazan Injection

Intervention Type DRUG

20/40/80 mg

Part1_placebo group

IV injection of test drugs by dose group

Group Type PLACEBO_COMPARATOR

Fexuprazan Injection placebo

Intervention Type DRUG

20/40/80 mg

Part2

All Participants take IV injection of test drugs

Group Type EXPERIMENTAL

Fexuprazan Injection_part 2

Intervention Type DRUG

20mg

Part3_test group

In the case of test group, take IV injection in the period 1 and take a tablet in the period 2

Group Type EXPERIMENTAL

Fexuprazan Injection_part 3

Intervention Type DRUG

40mg

Fexuprazan tablet

Intervention Type DRUG

40mg

Part3_reference group

In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2

Group Type ACTIVE_COMPARATOR

Fexuprazan Injection_part 3

Intervention Type DRUG

40mg

Fexuprazan tablet

Intervention Type DRUG

40mg

Interventions

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Fexuprazan Injection

20/40/80 mg

Intervention Type DRUG

Fexuprazan Injection placebo

20/40/80 mg

Intervention Type DRUG

Fexuprazan Injection_part 2

20mg

Intervention Type DRUG

Fexuprazan Injection_part 3

40mg

Intervention Type DRUG

Fexuprazan tablet

40mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

Exclusion Criteria

1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes