Phase 1 Study to Evaluate the Safety and Drug-Drug Interactions in Healthy Adult Participants

Ahn-Gook Pharmaceuticals Co.,Ltd36 enrolled

Overview

This Phase 1 study will evaluate the safety and drug-drug interactions of AG2203L and AG2203E in healthy adult participants. Participants will receive AG2203L and AG2203E alone and in combination during three treatment periods according to one of six randomly assigned treatment sequences.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Bronchitis

Interventions

AG2203LDRUG

Multiple doses of 1 tablet three times daily under fasting conditions, followed by a single dose of 1 tablet once daily under fasting conditions.

AG2203EDRUG

Multiple doses of 1 capsule three times daily under fasting conditions, followed by a single dose of 1 capsule once daily under fasting conditions.

AG2203L+AG2203EDRUG

Multiple doses of 1 tablet and 1 capsule co-administered three times daily under fasting conditions, followed by a single dose of 1 tablet and 1 capsule co-administered once daily under fasting conditions.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals aged 19 years or older at the time of screening. * Individuals with a body mass index (BMI) of 18-30 kg/m². * Individuals who are considered eligible for participation by the principal investigator based on the results of diagnostic tests and other screening assessments specified according to the characteristics of the investigational products. Exclusion Criteria: * Individuals who participated in a bioequivalence study or another clinical trial and received an investigational product within 30 days before the start of this study. * Individuals who consumed alcohol regularly within 1 month before the start of this study. * Individuals with a known hypersensitivity to either investigational product or any of its components.

Locations (1)

Kyungpook National University Hospital

Daegu, South Korea

Outcomes

Primary Outcomes

AUCt,ss AG2203L and AG2203E

Time frame: 0~12 hours post-dose

Cmax,ss AG2203L and AG2203E

Time frame: 0~12 hours post-dose

Data from ClinicalTrials.gov

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