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

An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03586037

Enrollment

Registered

2018-07-13

Start date

2018-06-12

Completion date

2018-08-20

Last updated

2018-10-09

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-2011 and AD-2012 in healthy male volunteers.

Detailed description

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

Interventions

DRUGAD-2011 10/20 mg

AD-2011 10/20 mg tablet

DRUGAD-2012 80mg

AD-2012 80mg tablet

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration	pre-dose to 24 hours	Cmax of the total ingredient of AD-2011 and AD-2012
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCtau of the total ingredient of AD-2011 and AD-2012

Secondary

Measure	Time frame	Description
Elimination half-life	pre-dose to 24 hours	t1/2 of the total ingredient of AD-2011 and AD-2012
Clearance	pre-dose to 24 hours	CL/F of the total ingredient of AD-2011 and AD-2012
Time to reach Cmax	pre-dose to 24 hours	Tmax of the total ingredient of AD-2011 and AD-2012
Number of participants with adverse events	From Day 1 up to Day 45	Incidence rate of adverse events
Volume of distribution	pre-dose to 24 hours	Vd/F of the total ingredient of AD-2011 and AD-2012
Concentration	pre-dose to 24 hours	Ctrough of the total ingredient of AD-2011 and AD-2012

Countries

South Korea

Outcome results

None listed

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