Young-Ran Yoon
Daegu, South Korea
Completed
NCT Number: NCT04755985
A Study to Compare PK, PD and Safety of the AD-213-B and AD-2132
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-B to AD-2132 in healthy volunteers.
Completed
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Notify MeKey information
Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
AD-213-B
Drug1 tablet administered before the breakfast during 5 days
AD-2132
Drug1 tablet administered before the breakfast during 5 days
Primary outcomes
-
AUCtau
Time frame: From Day 1 up to Day 17
Evaluation PK after multiple dose
-
The change of Integrated gastric acidity(%) from baseline
Time frame: 4 times from Day -1 to Day 17
Evaluation PD after multiple dose
Secondary outcomes
-
Cmax
Time frame: Day 1
Evaluation PK after single dose
-
AUClast
Time frame: Day 1
Evaluation PK after single dose
-
AUCinf
Time frame: Day 1
Evaluation PK after single dose
-
Tmax
Time frame: Day 1
Evaluation PK after single dose
-
t1/2
Time frame: Day 1
Evaluation PK after single dose
-
CL/F
Time frame: Day 1
Evaluation PK after single dose
-
Vd/F
Time frame: Day 1
Evaluation PK after single dose
-
Cmax,ss
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
Cmin,ss
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
AUCinf
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
Tmax,ss
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
t1/2
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
CLss/F
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
Vdss/F
Time frame: Day 1 up to Day 17
Evaluation PK after multiple dose
-
The change of Integrated gastric acidity(mmol∙hr/L) from baseline
Time frame: 4 times from Day -1 to Day 17
Evaluation PD after multiple dose
-
Percentage of time to maintain gastric pH 4.0 or higher
Time frame: 4 times from Day -1 to Day 17
Evaluation PD after multiple dose
Sponsors and collaborators
Lead sponsor
Addpharma Inc.
Industry
Registry information
Official study title
A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-B and AD-2132 After Oral Administration in Healthy Adult Subjects
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Feb 16, 2021
- Registry last updated
- Aug 6, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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