A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

April 10, 2025 updated by: Addpharma Inc.

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Study Type

Interventional

Enrollment (Estimated)

48

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body weight equal to or greater than 50kg (Female 45kg) 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:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

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 (RT)
Period 1: Reference (PA-111A), Period 2: Test (PA-111)
Drug: PA-111
PA-111 1Tab., Per Oral
Drug: PA-111A
PA-111A 1Capsule., Per Oral
Experimental: Sequence A (TR)
Period 1: Test (PA-111), Period 2: Reference (PA-111A),
Drug: PA-111
PA-111 1Tab., Per Oral
Drug: PA-111A
PA-111A 1Capsule., Per Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration of drug in plasma (Cmax)
Time Frame: pre-dose (0hour) to 72hours
Cmax of PA-111
pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time Frame: pre-dose (0hour) to 72hours
AUCt of PA-111
pre-dose (0hour) to 72hours

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-111BE

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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