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A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232 in Healthy Adult Volunteers Under Fasting Conditions

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07538466
Enrollment
50
Registered
2026-04-20
Start date
2026-04-01
Completion date
2026-05-01
Last updated
2026-04-20

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

Conditions

Diabetes Mellitus

Brief summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232

Interventions

DRUGAD-123

AD-123 Oral Tablet

DRUGAD-1231 and AD-1232

AD-1231 Oral Tablet + AD-1232 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 No maximum
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 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 of AD-123
Area under the plasma concentration-time curve during dosing interval (AUCt)pre-dose to 72 hoursAUCt of AD-123

Countries

South Korea

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026