Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

July 20, 2021 updated by: Addpharma Inc.

A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Study Type

Interventional

Enrollment (Actual)

25

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 to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male between 19 and 50 years of age at the time of screening
  • Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Exclusion Criteria:

  • Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
  • Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
  • A person who has a history of drug abuse
  • AST, ALT, Total bilirubin values over than 2 times of UNL at screening
  • Creatinine clearance under 80mL/min

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 1
Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 2
Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 3
Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 4
Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 5
Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 6
Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
Drug: AD-2101
AD-2101 16/5mg
Drug: AD-2102
AD-2102 25mg
Drug: AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration
Time Frame: pre-dose to 24 hours
Cmax,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Area under the plasma concentration versus time curve
Time Frame: pre-dose to 24 hours
AUCt,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach Cmax
Time Frame: pre-dose to 24 hours
Tmax,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Clearance
Time Frame: pre-dose to 24 hours
CLss/F of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Bottom Plasma Concentration
Time Frame: pre-dose to 24 hours
Cmin,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Number of participants with adverse events
Time Frame: From Day 1 up to Day 66
Incidence rate of adverse events
From Day 1 up to Day 66

Collaborators and Investigators

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

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: HyeWon Chung, Korea University Guro Hospital

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)

November 16, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-210DDI

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.

Clinical Trials on Hypertension

Clinical Trials on AD-2101

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe