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

Primary Purpose

Hyperlipidemias, Hypertension

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AD-2071 10/20mg

AD-2072 80/5mg

AD-2071 10/20mg + AD2072 80/5mg

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequence 1

Arm Description

Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD

Outcomes

Primary Outcome Measures

Peak Plasma Concentration

Cmax of the total ingredient of AD-2071 and AD-2072

Area under the plasma concentration versus time curve

AUCtau of the total ingredient of AD-2071 and AD-20172

Secondary Outcome Measures

Time to reach Cmax

Tmax of the total ingredient of AD-2071 and AD-2072

Elimination half-life

t1/2 of the total ingredient of AD-2071 and AD-2072

Clearance

CL/F of the total ingredient of AD-2071 and AD-2072

Volume of distribution

Vd/F of the total ingredient of AD-2071 and AD-2072

Number of participants with adverse events

Incidence rate of adverse events

Full Information

NCT ID

NCT03632668

First Posted

August 13, 2018

Last Updated

July 2, 2019

Sponsor

Addpharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03632668

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 28, 2018 (Actual)

Primary Completion Date

January 24, 2019 (Actual)

Study Completion Date

January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD

Intervention Type

Drug

Intervention Name(s)

AD-2071 10/20mg

Intervention Description

AD-2071 10/20 mg tablet

Intervention Type

Drug

Intervention Name(s)

AD-2072 80/5mg

Intervention Description

AD-2072 80/5mg tablet

Intervention Type

Drug

Intervention Name(s)

AD-2071 10/20mg + AD2072 80/5mg

Intervention Description

AD-2071 10/20 mg + AD-2072 80/5mg tablet

Primary Outcome Measure Information:

Title

Peak Plasma Concentration

Description

Cmax of the total ingredient of AD-2071 and AD-2072

Time Frame

pre-dose to 24 hours

Title

Area under the plasma concentration versus time curve

Description

AUCtau of the total ingredient of AD-2071 and AD-20172

Time Frame

pre-dose to 24 hours

Secondary Outcome Measure Information:

Title

Time to reach Cmax

Description

Tmax of the total ingredient of AD-2071 and AD-2072

Time Frame

pre-dose to 24 hours

Title

Elimination half-life

Description

t1/2 of the total ingredient of AD-2071 and AD-2072

Time Frame

pre-dose to 24 hours

Title

Clearance

Description

CL/F of the total ingredient of AD-2071 and AD-2072

Time Frame

pre-dose to 24 hours

Title

Volume of distribution

Description

Vd/F of the total ingredient of AD-2071 and AD-2072

Time Frame

pre-dose to 24 hours

Title

Number of participants with adverse events

Description

Incidence rate of adverse events

Time Frame

From Day 1 up to Day 46

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Jin Jang, M.D.,Ph.D

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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