A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

Phase 1Enrolling By InvitationNCT07495514

Addpharma Inc.60 enrolled

Overview

An open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the food effect on the safety and the pharmacokinetics of AD-117 in healthy adult volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mixed Dyslipidemia Food Effect Study of AD-117

Interventions

AD-117DRUG

AD-117 1Tab., Per Oral

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * Healthy volunteers aged ≥19 and \<65 years 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

Locations (1)

H PLUS YANGJI HOSPITAL, Seoul,

Seoul, South Korea

Outcomes

Primary Outcomes

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-117

Time frame: 0-72 hours

Area under the plasma concentration-time curve during dosing interval (AUCt)

AUCt of AD-117

Time frame: 0-72 hours

Data from ClinicalTrials.gov

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