Status:
COMPLETED
A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
Lead Sponsor:
Addpharma Inc.
Conditions:
Gastroesophagus Reflux Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy adults over 19 years of age.
- Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
- Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
- Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
Exclusion
- A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
- As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
- As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
- Subjects who judged ineligible by the investigator.
Key Trial Info
Start Date :
October 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04690868
Start Date
October 15 2021
End Date
December 21 2021
Last Update
April 27 2022
Active Locations (1)
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1
Kyungpook National University Hospital
Daegu, South Korea