to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection
Phase 1
Not yet recruiting
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Interventions
- Registration Number
- NCT06437951
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Healthy adult volunteers aged 19 to 50 at the time of screening tests
- 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
- 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.)
- 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
- A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
Exclusion Criteria
- 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
- 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
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- A person who has been tested positive for Helicobacter pylori
- Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part1_test group Fexuprazan Injection IV injection of test drugs by dose group Part2 Fexuprazan Injection_part 2 All Participants take IV injection of test drugs Part1_placebo group Fexuprazan Injection placebo IV injection of test drugs by dose group Part3_test group Fexuprazan Injection_part 3 In the case of test group, take IV injection in the period 1 and take a tablet in the period 2 Part3_test group Fexuprazan tablet In the case of test group, take IV injection in the period 1 and take a tablet in the period 2 Part3_reference group Fexuprazan tablet In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2 Part3_reference group Fexuprazan Injection_part 3 In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method