A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05128591

Enrollment

Registered

2021-11-22

Start date

2021-11-09

Completion date

2021-12-31

Last updated

2022-03-08

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

Conditions

Embolism and Thrombosis

Brief summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.

Detailed description

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.

Interventions

DRUGRivaroxaban 18mg Oral Tablet

AD-109 (Rivaroxaban 18mg) Oral Tablet

DRUGRivaroxaban 20 MG Oral Tablet

AD-1091 (Rivaroxaban 20mg) Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit

Exclusion criteria

* Patients with Medical history increasing the risk of bleeding

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	pre-dose to 34 hours	Cmax of Rivaroxaban
Area Under the Curve in time plot (AUCt)	pre-dose to 34 hours	AUCt of Rivaroxaban

Countries

South Korea

Outcome results

None listed

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