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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Embolism and Thrombosis

Treatments: Drug: Rivaroxaban 18mg Oral Tablet; Drug: Rivaroxaban 20 MG Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05128591

AD-109BE

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

Arm A-Rivaroxaban

Experimental group

Description:

Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)

Treatment:

Drug: Rivaroxaban 18mg Oral Tablet

Drug: Rivaroxaban 20 MG Oral Tablet

Arm B-Rivaroxaban

Experimental group

Description:

Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091

Treatment:

Drug: Rivaroxaban 18mg Oral Tablet

Drug: Rivaroxaban 20 MG Oral Tablet