Safety, PK, and PD Comparison of UI059 and UIC202201 in Healthy Volunteers
ConditionGastro Esophageal Reflux Disorder
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea United Pharm. Inc.
About this trial
A randomized, open-label, multiple-dose, crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers aged 19 years or older at the time of screening.
Body weight: ≥50.0kg for males, ≥45.0kg for females.
BMI: ≥18.0mg/m2 and ≤ 30.0kg/m2
Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings based on medical examination.
Disqualifiers
Current or past history of clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal diseases.
History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy, hernia repair, or dental procedures) that may affect the absorption of the investigational product.
Pregnant (positive Urine-HCG test) or breastfeeding women.
History of clinically significant hypersensitivity (e.g., anaphylaxis or angioedema) to the investigational product ingredients, excipients, or other drugs (e.g., aspirin, penicillin-type antibiotics, macrolide antibiotics, etc.).
Trial design
Design model
Crossover
Treatments tested in this trial
UI059
Drugtake UI059 once a day for 7 days
UIC202201
Drugtake UIC202201 once a day for 7 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: UI059Experimental treatment 1 intervention
Group B: UIC202201Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
AUCτ,ss
Time frame
day1: 0-24 hours / day 5, day 6: 0 hour / day 7: 0-24 hours2
Percent decrease from baseline in integrated gastric acidity
Time frame
Day -1(0 hour) - Day 1(0 hour) / Day1(0 hour) - Day2(0 hour) / Day7(0 hour) - Day7(24 hour)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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