Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04600284

Enrollment

Registered

2020-10-23

Start date

2020-11-16

Completion date

2021-04-30

Last updated

2021-07-21

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

Conditions

Hypertension

Brief summary

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Detailed description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Interventions

DRUGAD-2101

AD-2101 16/5mg

DRUGAD-2102

AD-2102 25mg

DRUGAD-2101 + AD-2102

AD-2101 16/5mg + AD-2102 25mg

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 above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Exclusion criteria

* Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric * Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery * A person who has a history of drug abuse * AST, ALT, Total bilirubin values over than 2 times of UNL at screening * Creatinine clearance under 80mL/min

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration	pre-dose to 24 hours	Cmax,ss of the total ingredient of AD-2101 and AD-2102
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCt,ss of the total ingredient of AD-2101 and AD-2102

Secondary

Measure	Time frame	Description
Time to reach Cmax	pre-dose to 24 hours	Tmax,ss of the total ingredient of AD-2101 and AD-2102
Clearance	pre-dose to 24 hours	CLss/F of the total ingredient of AD-2101 and AD-2102
Bottom Plasma Concentration	pre-dose to 24 hours	Cmin,ss of the total ingredient of AD-2101 and AD-2102
Number of participants with adverse events	From Day 1 up to Day 66	Incidence rate of adverse events

Countries

South Korea

Outcome results

None listed

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