NCT05202405

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

July 20, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 9, 2022

Last Update Submit

July 19, 2022

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Cmax of AD-221

    pre-dose to 72 hours

  • Area Under the Curve in time plot (AUCt)

    AUCt of AD-221

    pre-dose to 72 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

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

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

Sequence B

EXPERIMENTAL

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

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

Interventions

AD-221DRUG

AD-221 Oral Tablet

Sequence ASequence B
AD-221A and AD-221BDRUG

AD-221A Oral Tablet + AD-221B Oral Tablet

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H+ Yangji Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Song J, Bae S, Yu KS, Lee S. Comparison of pharmacokinetics of a fixed-dose combination of atorvastatin/ezetimibe 5 mg/10 mg versus separate tablets in healthy subjects. Transl Clin Pharmacol. 2025 Mar;33(1):40-49. doi: 10.12793/tcp.2025.33.e5. Epub 2025 Mar 24.

    PMID: 40206873DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

January 5, 2022

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

July 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)