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

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Hypertension; Hyperlipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07312773

AD-231DDI

Details and patient eligibility

About

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

Enrollment: 55 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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55 participants in 2 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Drug: Treatment A(AD-231A)

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

Arm B

Experimental group

Description:

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

Treatment:

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

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