A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-236A and AD-236B

Phase 1Not Yet RecruitingNCT07730567

Addpharma Inc.44 enrolled

Overview

To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipidemia Diabete Type 2

Interventions

Treatment A(AD-236A)DRUG

AD-236A Oral Tablet

Treatment B(AD-236B)DRUG

AD-236B Oral Tablet

Treatment C(AD-236A+AD-236B)DRUG

AD-236A+AD-236B Oral Tablet

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult volunteers aged ≥19 and ≤55 years at the time of the screening visit * Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the 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+ Yangji Hospital, Seoul,

Seoul, South Korea

Outcomes

Primary Outcomes

1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)

AUCτ,ss

Time frame: pre-dose (0hour) to 24 hours post-dose

Maximum concentration of drug in plasma at steady state (Cmax,ss)

Cmax,ss

Time frame: pre-dose (0hour) to 24 hours post-dose

Central Contacts

Heeyoung Hong

CONTACT

821094710619 hyhong@addpharma.co.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.