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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06437951
Other study ID # DW_DWJ1521104
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date July 2024
Est. completion date May 2025

Study information

Verified date May 2024
Source Daewoong Pharmaceutical Co. LTD.
Contact Sujong Lee, Ph.D
Phone 027408910
Email leesj0323@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date May 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fexuprazan Injection
20/40/80 mg
Fexuprazan Injection placebo
20/40/80 mg
Fexuprazan Injection_part 2
20mg
Fexuprazan Injection_part 3
40mg
Fexuprazan tablet
40mg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type Measure Description Time frame Safety issue
Primary PK of Fexuprazan 1. Blood and urinary concentrations of Fexuprazan by part 0 and 72hour
Primary PK of metabolite 1. Blood and urinary concentrations of metabolite by part 0 and 72hour
Primary PD of Fexuprazan pH monitoring up to 15days
See also
  Status Clinical Trial Phase
Completed NCT04080726 - Efficacy and Safety of HIP1601 Capsule Phase 3
Completed NCT00562094 - Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS) N/A
Completed NCT03184324 - Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study) Phase 2