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

Gastroesophagus Reflux Disease Clinical Trial

Official title:

A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690868
• Other study ID #: AD-213PK/PD
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: November 2021
• Source: Addpharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 21, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophagus Reflux Disease

Intervention

Drug:
• AD-213-A
1 tablet administered before the breakfast during 5 days
• AD-2131
1 tablet administered before the breakfast during 5 days

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCtau	Evaluation PK after multiple dose	From Day 1 up to Day 17
Primary	Integrated gastric acidity(%Decrease form baseline)	Evaluation PD after multiple dose	4 times from Day -1 to Day 17
Secondary	Cmax	Evaluation PK after single dose	Day 1
Secondary	AUClast	Evaluation PK after single dose	Day 1
Secondary	AUCinf	Evaluation PK after single dose	Day 1
Secondary	Tmax	Evaluation PK after single dose	Day 1
Secondary	t1/2	Evaluation PK after single dose	Day 1
Secondary	CL/F	Evaluation PK after single dose	Day 1
Secondary	Vd/F	Evaluation PK after single dose	Day 1
Secondary	Cmax,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	Cmin,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	AUCinf	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	Tmax,ss	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	t1/2	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	CLss/F	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	Vdss/F	Evaluation PK after multiple dose	From Day 1 up to Day 17
Secondary	Integrated gastric acidity(Variations form baseline)	Evaluation PD after multiple dose	4 times from Day -1 to Day 17
Secondary	Percentage of time to maintain gastric pH 4.0 or higher	Evaluation PD after multiple dose	4 times from Day -1 to Day 17