An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers

Addpharma Inc.1 site in 1 country64 target enrollmentJanuary 5, 2022

ConditionsHyperlipidemias

InterventionsAD-221 AD-221A and AD-221B

DrugsAD-221 AD-221A and AD-221B

Overview

Phase: Phase 1
Intervention: AD-221
Conditions: Hyperlipidemias
Sponsor: Addpharma Inc.
Enrollment: 64
Locations: 1
Primary Endpoint: Area Under the Curve in time plot (AUCt)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 5, 2022

End Date

March 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Addpharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

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