Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072

July 2, 2019 updated by: Addpharma Inc.

An Open-label, Two-period, One-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in Healthy Male Volunteers

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.

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-2071 and AD-2072.

Study Type

Interventional

Enrollment (Actual)

38

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male between 19 and 50 years of age at the time of screening
  • Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2

Exclusion Criteria:

  • Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric
  • Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
  • HDL values less than 35 mg/dL
  • AST, ALT values over than 1.5 times of ULN at screening
  • A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
Drug: AD-2071 10/20mg
AD-2071 10/20 mg tablet
Drug: AD-2072 80/5mg
AD-2072 80/5mg tablet
Drug: AD-2071 10/20mg + AD2072 80/5mg
AD-2071 10/20 mg + AD-2072 80/5mg tablet

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 of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Area under the plasma concentration versus time curve
Time Frame: pre-dose to 24 hours
AUCtau of the total ingredient of AD-2071 and AD-20172
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 of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Elimination half-life
Time Frame: pre-dose to 24 hours
t1/2 of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Clearance
Time Frame: pre-dose to 24 hours
CL/F of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Volume of distribution
Time Frame: pre-dose to 24 hours
Vd/F of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Number of participants with adverse events
Time Frame: From Day 1 up to Day 46
Incidence rate of adverse events
From Day 1 up to Day 46

Collaborators and Investigators

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

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: In-Jin Jang, M.D.,Ph.D, Seoul National University 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)

September 28, 2018

Primary Completion (Actual)

January 24, 2019

Study Completion (Actual)

January 24, 2019

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-207DDI

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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