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

July 19, 2022 updated by: Addpharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
Drug: AD-221
AD-221 Oral Tablet
Drug: AD-221A and AD-221B
AD-221A Oral Tablet + AD-221B Oral Tablet
Experimental: Sequence B
Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
Drug: AD-221
AD-221 Oral Tablet
Drug: AD-221A and AD-221B
AD-221A Oral Tablet + AD-221B Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: pre-dose to 72 hours
Cmax of AD-221
pre-dose to 72 hours
Area Under the Curve in time plot (AUCt)
Time Frame: pre-dose to 72 hours
AUCt of AD-221
pre-dose to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

March 4, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-221PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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