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
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hyperlipidemias

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