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

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: AD-221; Drug: AD-221A and AD-221B

• Registration Number: NCT05202405
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-05
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-21
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	AD-221A and AD-221B	Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
Sequence A	AD-221A and AD-221B	Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
Sequence B	AD-221	Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
Sequence A	AD-221	Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)

Primary Outcome Measures

Name	Time	Method
Area Under the Curve in time plot (AUCt)	pre-dose to 72 hours	AUCt of AD-221
Peak Plasma Concentration (Cmax)	pre-dose to 72 hours	Cmax of AD-221

Trial Locations

Locations (1)

H+ Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of