A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
Phase 1
Completed
- Conditions
- Embolism and Thrombosis
- Interventions
- 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.
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
Read More
Exclusion Criteria
- Patients with Medical history increasing the risk of bleeding
Read More
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H+ Yangji Hospital
🇰🇷Seoul, Korea, Republic of