Evaluate the Pharmacokinetic Interaction and the Safety of AD-2321 and AD-2322

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Hypertension

Treatments: Drug: Treatment C(AD-2321+AD-2322); Drug: Treatment B(AD-2322); Drug: Treatment A(AD-2321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07312799

AD-232DDI

Details and patient eligibility

About

To evaluate the pharmacokinetic interactions of AD-2321, AD-2322 in healthy adult volunteers.

Enrollment: 41 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Arm A

Experimental group

Description:

Period 1 : Treatment A(AD-2321), Period 2 : Treatment C(AD-2321+AD-2322)

Treatment:

Drug: Treatment A(AD-2321)

Drug: Treatment C(AD-2321+AD-2322)

Arm B

Experimental group

Description:

Period 1 : Treatment B(AD-2322), Period 2 : Treatment C(AD-2321+AD-2322)

Treatment:

Drug: Treatment B(AD-2322)

Drug: Treatment C(AD-2321+AD-2322)