Erosive Gastroesophageal Reflux Disease
Conditions
Brief summary
to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
Interventions
DRUGFexuprazan Injection
20/40/80 mg
DRUGFexuprazan Injection placebo
20/40/80 mg
DRUGFexuprazan Injection_part 2
20mg
DRUGFexuprazan Injection_part 3
40mg
DRUGFexuprazan tablet
40mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK of Fexuprazan | 0 and 72hour | 1\. Blood and urinary concentrations of Fexuprazan by part |
| PK of metabolite | 0 and 72hour | 1\. Blood and urinary concentrations of metabolite by part |
| PD of Fexuprazan | up to 15days | pH monitoring |
Contacts
Primary ContactSujong Lee, Ph.D
Outcome results
None listed