NCT05128591

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 8, 2022

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

November 10, 2021

Last Update Submit

February 20, 2022

Conditions

Embolism and Thrombosis

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Cmax of Rivaroxaban

    pre-dose to 34 hours

  • Area Under the Curve in time plot (AUCt)

    AUCt of Rivaroxaban

    pre-dose to 34 hours

Study Arms (2)

Arm A-Rivaroxaban

EXPERIMENTAL

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

Drug: Rivaroxaban 18mg Oral TabletDrug: Rivaroxaban 20 MG Oral Tablet

Arm B-Rivaroxaban

EXPERIMENTAL

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

Drug: Rivaroxaban 18mg Oral TabletDrug: Rivaroxaban 20 MG Oral Tablet

Interventions

Rivaroxaban 18mg Oral TabletDRUG

AD-109 (Rivaroxaban 18mg) Oral Tablet

Arm A-RivaroxabanArm B-Rivaroxaban
Rivaroxaban 20 MG Oral TabletDRUG

AD-1091 (Rivaroxaban 20mg) Oral Tablet

Arm A-RivaroxabanArm B-Rivaroxaban

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with Medical history increasing the risk of bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H+ Yangji Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Embolism and Thrombosis

Interventions

RivaroxabanTablets

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

November 9, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 8, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)