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

NCT ID: NCT03632668

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2019-01-24

Brief Summary

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

Detailed Description

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

Conditions

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Hyperlipidemias Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

AD-2071 10/20mg

Intervention Type DRUG

AD-2071 10/20 mg tablet

AD-2072 80/5mg

Intervention Type DRUG

AD-2072 80/5mg tablet

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

Intervention Type DRUG

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

Interventions

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AD-2071 10/20mg

AD-2071 10/20 mg tablet

Intervention Type DRUG

AD-2072 80/5mg

AD-2072 80/5mg tablet

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-207DDI

Identifier Type: -

Identifier Source: org_study_id

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