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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03632668

Enrollment

Registered

2018-08-15

Start date

2018-09-28

Completion date

2019-01-24

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias, Hypertension

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.

Interventions

DRUGAD-2071 10/20mg

AD-2071 10/20 mg tablet

DRUGAD-2072 80/5mg

AD-2072 80/5mg tablet

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration	pre-dose to 24 hours	Cmax of the total ingredient of AD-2071 and AD-2072
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCtau of the total ingredient of AD-2071 and AD-20172

Secondary

Measure	Time frame	Description
Clearance	pre-dose to 24 hours	CL/F of the total ingredient of AD-2071 and AD-2072
Time to reach Cmax	pre-dose to 24 hours	Tmax of the total ingredient of AD-2071 and AD-2072
Number of participants with adverse events	From Day 1 up to Day 46	Incidence rate of adverse events
Volume of distribution	pre-dose to 24 hours	Vd/F of the total ingredient of AD-2071 and AD-2072
Elimination half-life	pre-dose to 24 hours	t1/2 of the total ingredient of AD-2071 and AD-2072

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026