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A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C

A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C in Healthy Adult Volunteers

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07312773
Enrollment
55
Registered
2025-12-31
Start date
2026-01-23
Completion date
2026-02-22
Last updated
2025-12-31

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.

Interventions

DRUGTreatment A(AD-231A)

AD-231A Oral Tablet

DRUGTreatment B(AD-231B+AD-231C)

AD-231B+AD-231C Oral Tablet

DRUGTreatment C(AD-231A+AD-231B+AD-231C)

AD-231A+AD-231B+AD-231C Oral Tablet

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adult volunteers aged ≥19 and \<65 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

Design outcomes

Primary

MeasureTime frameDescription
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)pre-dose (0hour) to 24 hours post-dose on Day 14AUCτ,ss
Maximum concentration of drug in plasma at steady state (Cmax,ss)pre-dose (0hour) to 24 hours post-dose on Day 14

Countries

South Korea

Contacts

Primary ContactJaeHun Jung
jhjung@addpharma.co.kr+8247679615

Outcome results

None listed

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