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

Addpharma Inc.38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Embolism and Thrombosis

Interventions

Rivaroxaban 18mg Oral TabletDRUG

AD-109 (Rivaroxaban 18mg) Oral Tablet

Rivaroxaban 20 MG Oral TabletDRUG

AD-1091 (Rivaroxaban 20mg) Oral Tablet

Eligibility

Sex: MALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

H+ Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Cmax of Rivaroxaban

Time frame: pre-dose to 34 hours

Area Under the Curve in time plot (AUCt)

AUCt of Rivaroxaban

Time frame: pre-dose to 34 hours

Data from ClinicalTrials.gov

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