A Clinical Trial to Assess the Pharmacokinetics and Safety of AD-229 Compared to AD-2291 in Healthy Adults

Addpharma

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Gastritis

Treatments: Drug: AD-229; Drug: AD-2291

Study type: Interventional

Funder types: Industry

Identifiers

NCT07385248

AD-229BE

Details and patient eligibility

About

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-229 and the administration of AD-2291 in healthy adults.

Enrollment: 28 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
• The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion criteria

• Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1 : Reference Drug(AD-2291), Period 2 : Test Drug(AD-229)

Treatment:

Drug: AD-2291

Drug: AD-229

Sequence B

Experimental group

Description:

Period 1 : Test Drug(AD-229), Period 2 : Reference Drug(AD-2291)

Treatment:

Drug: AD-2291

Drug: AD-229