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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05128591
Other study ID # AD-109BE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 9, 2021
Est. completion date December 31, 2021

Study information

Verified date November 2021
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 38
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban 18mg Oral Tablet
AD-109 (Rivaroxaban 18mg) Oral Tablet
Rivaroxaban 20 MG Oral Tablet
AD-1091 (Rivaroxaban 20mg) Oral Tablet

Locations

Country Name City State
Korea, Republic of H+ Yangji Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) Cmax of Rivaroxaban pre-dose to 34 hours
Primary Area Under the Curve in time plot (AUCt) AUCt of Rivaroxaban pre-dose to 34 hours
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