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Not yet recruitingNCT07312773Updated Dec 31, 2025

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

A Phase 1 interventional study of Treatment A(AD-231A) and Treatment B(AD-231B+AD-231C) in Hypertension and Hyperlipidemia, sponsored by Addpharma Inc.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Addpharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
19 Years to 64 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension
  • Hyperlipidemia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 55 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Arm A

    Period 1 : Treatment A(AD-231A), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C)

    Drug: Treatment A(AD-231A) · Drug: Treatment C(AD-231A+AD-231B+AD-231C)

  • Experimental
    Arm B

    Period 1 : Treatment B(AD-231B+AD-231C), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C)

    Drug: Treatment B(AD-231B+AD-231C) · Drug: Treatment C(AD-231A+AD-231B+AD-231C)

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

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)

    AUCτ,ss

    Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14

  2. Maximum concentration of drug in plasma at steady state (Cmax,ss)

    Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14

07

Study locations

1 site
  • H+ Yangji Hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07312773
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
Dec 31, 2025
Start date
Jan 23, 2026 (estimated)
Primary completion
Feb 7, 2026 (estimated)
Completion
Feb 22, 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

JaeHun Jung
Contact
jhjung@addpharma.co.kr
+8247679615

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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