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A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C in Healthy Adult Volunteers

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590167
Enrollment
60
Registered
2026-05-15
Start date
2026-06-01
Completion date
2026-07-01
Last updated
2026-05-15

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

Conditions

Dyslipidemia, Hypertension

Brief summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

Interventions

DRUGAD-231

AD-231 Oral Tablet

DRUGAD-231A, AD-231D and AD-231C

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

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* 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 and under 65 years 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

MeasureTime frameDescription
Maximum concentration of drug in plasma (Cmax)pre-dose to 72 hoursCmax
Area under the plasma concentration-time curve during dosing interval (AUCt)pre-dose to 72 hoursAUCt

Countries

South Korea

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026