A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131

Phase 1

Completed

• Conditions: Gastroesophagus Reflux Disease
• Interventions: Drug: AD-213-A; Drug: AD-2131

• Registration Number: NCT04690868
• Lead Sponsor: Addpharma Inc.

Brief Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-31
• Study Start: 2021-10-15
• Status Verified: 2021-11
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-21
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM 1	AD-213-A	Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)
ARM 1	AD-2131	Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)
ARM 2	AD-213-A	Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)
ARM 2	AD-2131	Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)

Primary Outcome Measures

Name	Time	Method
Integrated gastric acidity(%Decrease form baseline)	4 times from Day -1 to Day 17	Evaluation PD after multiple dose
AUCtau	From Day 1 up to Day 17	Evaluation PK after multiple dose

Secondary Outcome Measures

Name	Time	Method
Cmax	Day 1	Evaluation PK after single dose
AUClast	Day 1	Evaluation PK after single dose
AUCinf	From Day 1 up to Day 17	Evaluation PK after multiple dose
Tmax	Day 1	Evaluation PK after single dose
t1/2	From Day 1 up to Day 17	Evaluation PK after multiple dose
CL/F	Day 1	Evaluation PK after single dose
Vd/F	Day 1	Evaluation PK after single dose
Cmax,ss	From Day 1 up to Day 17	Evaluation PK after multiple dose
Cmin,ss	From Day 1 up to Day 17	Evaluation PK after multiple dose
Tmax,ss	From Day 1 up to Day 17	Evaluation PK after multiple dose
CLss/F	From Day 1 up to Day 17	Evaluation PK after multiple dose
Vdss/F	From Day 1 up to Day 17	Evaluation PK after multiple dose
Integrated gastric acidity(Variations form baseline)	4 times from Day -1 to Day 17	Evaluation PD after multiple dose
Percentage of time to maintain gastric pH 4.0 or higher	4 times from Day -1 to Day 17	Evaluation PD after multiple dose

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of