A Study to Compare to PK Characteristics and Safety Profiles Between AD-117 and AD-117A

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-117 Compared to AD-117A in Healthy Adult Volunteers Under Fed State Conditions

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07152873

Enrollment

Registered

2025-09-03

Start date

2025-12-01

Completion date

2026-03-31

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Dyslipidemia

Brief summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-117 in healthy subjects.

Interventions

DRUGAD-117

AD-117 1Tab., Per Oral

DRUGAD-117A

AD-117A 1Tab., Per Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Maximum concentration of drug in plasma (Cmax)	pre-dose (0hour) to 72hours	Cmax of AD-117
Area under the plasma concentration-time curve during dosing interval (AUCt)	pre-dose (0hour) to 72hours	AUCt of AD-117

Countries

South Korea

Contacts

Primary ContactDasom Kim

dskim@addpharma.co.kr+82-31-891-5572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026