A Study to Compare PK, PD and Safety of the AD-214 and AD-2141

Addpharma

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: AD-2141; Drug: AD-214

Study type: Interventional

Funder types: Industry

Identifiers

NCT05062876

AD-214PK/PD-03

Details and patient eligibility

About

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.

Full description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 compared with administration of AD-2141 in healthy volunteers.

Enrollment: 41 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~50 years in healthy volunteers
• BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2
• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion criteria

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
• 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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41 participants in 2 patient groups

R-T

Active Comparator group

Description:

Period 1 : Test Drug(AD-214) Period 2 : Reference Drug(AD-2141)

Treatment:

Drug: AD-214

Drug: AD-2141

T-R

Active Comparator group

Description:

Period 1 : Reference Drug(AD-2141) Period 2 : Test Drug(AD-214)

Treatment:

Drug: AD-214

Drug: AD-2141