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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Gastroesophagus Reflux Disease

Treatments: Drug: AD-213-A; Drug: AD-2131

Study type: Interventional

Funder types: Industry

Identifiers

NCT04690868

AD-213PK/PD

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

ARM 1

Experimental group

Description:

Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)

Treatment:

Drug: AD-2131

Drug: AD-213-A

ARM 2

Experimental group

Description:

Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)

Treatment:

Drug: AD-2131

Drug: AD-213-A