Back to resultsA Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
Primary Purpose
Embolism and Thrombosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rivaroxaban 18mg Oral Tablet
Rivaroxaban 20 MG Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Embolism and Thrombosis
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
Sites / Locations
- H+ Yangji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A-Rivaroxaban
Arm B-Rivaroxaban
Arm Description
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Cmax of Rivaroxaban
Area Under the Curve in time plot (AUCt)
AUCt of Rivaroxaban
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05128591
Brief Title
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism and Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A-Rivaroxaban
Arm Type
Experimental
Arm Description
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Arm Title
Arm B-Rivaroxaban
Arm Type
Experimental
Arm Description
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 18mg Oral Tablet
Intervention Description
AD-109 (Rivaroxaban 18mg) Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 20 MG Oral Tablet
Intervention Description
AD-1091 (Rivaroxaban 20mg) Oral Tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of Rivaroxaban
Time Frame
pre-dose to 34 hours
Title
Area Under the Curve in time plot (AUCt)
Description
AUCt of Rivaroxaban
Time Frame
pre-dose to 34 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
H+ Yangji Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
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