Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2018-08-20

Brief Summary

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The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.

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Detailed Description

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To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Conditions

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Hyperlipidemias Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 2

Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 3

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 4

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 5

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 6

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Group Type EXPERIMENTAL

AD-2011 10/20 mg

Intervention Type DRUG

AD-2011 10/20 mg tablet

AD-2012 80mg

Intervention Type DRUG

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Interventions

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AD-2011 10/20 mg

AD-2011 10/20 mg tablet

Intervention Type DRUG

AD-2012 80mg

AD-2012 80mg tablet

Intervention Type DRUG

AD-2011 10/20 mg + AD-2012 80mg

AD-2011 10/20 mg + AD-2012 80mg 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
* AST, ALT values over than 1.5 times of ULN at screening
* HDL values less than 35 mg/dL
* 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