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
Overview
- Phase
- Phase 1
- Intervention
- Rivaroxaban 18mg Oral Tablet
- Conditions
- Embolism and Thrombosis
- Sponsor
- Addpharma Inc.
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm A-Rivaroxaban
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Intervention: Rivaroxaban 18mg Oral Tablet
Arm A-Rivaroxaban
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Intervention: Rivaroxaban 20 MG Oral Tablet
Arm B-Rivaroxaban
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Intervention: Rivaroxaban 18mg Oral Tablet
Arm B-Rivaroxaban
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Intervention: Rivaroxaban 20 MG Oral Tablet
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: pre-dose to 34 hours
Cmax of Rivaroxaban
Area Under the Curve in time plot (AUCt)
Time Frame: pre-dose to 34 hours
AUCt of Rivaroxaban