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Not yet recruiting NCT07717749

A Study to Evaluate the Safety, Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects

Phase I Interventional Chronic Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-118, AD-1181, AD-118, AD-1181.
Who it may be relevant to
Registry conditions: Chronic Heart Failure. Basic parameters: 19 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers

Overview

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

Interventions

  • Drug AD-118, AD-1181
    Single-dose oral administration of AD-118, according to randomized treatment sequence in a 2-period crossover design.
  • Drug AD-118, AD-1181
    Single-dose oral administration of AD-1181, according to randomized treatment sequence in a 2-period crossover design.

Primary outcome measures

  • Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: [Time Frame: pre-dose (0hour) to 36hours]]
  • Maximum concentration of drug in plasma (Cmax) [Time frame: Time Frame: pre-dose (0hour) to 36hours]]

Eligibility criteria

Inclusion criteria

  • Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • Subjects aged 19 years or older and under 65 years at 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • H Plus Yangji Hospital — Seoul

Identifiers

NCT: NCT07717749 · AD-118BE-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗