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NCT05202405 Clinical Trial

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

Hyperlipidemias Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05202405
Other study ID # AD-221PK
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 5, 2022
Est. completion date March 4, 2022

Study information
Verified date January 2022
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date March 4, 2022
Est. primary completion date March 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AD-221
AD-221 Oral Tablet
• AD-221A and AD-221B
AD-221A Oral Tablet + AD-221B Oral Tablet

Locations
Country Name City State
Korea, Republic of H+ Yangji Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) Cmax of AD-221 pre-dose to 72 hours
Primary Area Under the Curve in time plot (AUCt) AUCt of AD-221 pre-dose to 72 hours
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