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

Phase 1

Completed

• Conditions: Embolism and Thrombosis
• Interventions: Drug: Rivaroxaban 18mg Oral Tablet; Drug: Rivaroxaban 20 MG Oral Tablet

• Registration Number: NCT05128591
• Lead Sponsor: Addpharma Inc.

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-09
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A-Rivaroxaban	Rivaroxaban 20 MG Oral Tablet	Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Arm B-Rivaroxaban	Rivaroxaban 20 MG Oral Tablet	Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Arm A-Rivaroxaban	Rivaroxaban 18mg Oral Tablet	Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Arm B-Rivaroxaban	Rivaroxaban 18mg Oral Tablet	Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

H+ Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of