A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B

Addpharma

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemias

Treatments: Drug: AD-221; Drug: AD-221A and AD-221B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05202405

AD-221PK

Details and patient eligibility

About

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

Full description

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Enrollment: 64 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight equal to or greater than 50kg and 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

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
• Subjects who judged ineligible by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)

Treatment:

Drug: AD-221A and AD-221B

Drug: AD-221

Sequence B

Experimental group

Description:

Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)

Treatment:

Drug: AD-221A and AD-221B

Drug: AD-221