Clinical Trials Logo
  1. Home
  2. Embolism and Thrombosis
  3. NCT05128591
  4. Details
NCT05128591 Clinical Trial

A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

Embolism and Thrombosis Clinical Trial

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

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
See also
  Status Clinical Trial Phase
Recruiting NCT04304651 - Screening for Occult Malignancy in Patients With Unprovoked Venous Thromboembolism N/A
Completed NCT00216866 - The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis Phase 2
Recruiting NCT05907564 - Aventus Thrombectomy System Pulmonary Embolism Clinical Study N/A
Completed NCT00670540 - Epidemiology of Thromboembolism Disease: A Cohort Study N/A
Recruiting NCT04263038 - Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism Phase 4
Recruiting NCT04388657 - COVID-19, bLOod Coagulation and Thrombosis
Completed NCT04439383 - Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients
Completed NCT01897103 - Platelet Activity in Vascular Surgery for Thrombosis and Bleeding N/A
Recruiting NCT04657120 - Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy N/A
Completed NCT02720328 - Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants Phase 4
Completed NCT01203098 - A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty Phase 2
Completed NCT00830570 - The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings N/A
Recruiting NCT05568966 - Collection of Blood Samples for New Diagnostic Devices 2 N/A
Not yet recruiting NCT06209892 - Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis N/A
Completed NCT01086215 - Registry of AngioJet Use in the Peripheral Vascular System N/A
Completed NCT02996851 - Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs N/A
Completed NCT00119457 - Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial) Phase 2
Recruiting NCT05853796 - Observational Dutch Young Symptomatic StrokE studY - nEXT
Terminated NCT02610608 - Medical Assistance for the Procreation and Risk of Thrombosis.
Completed NCT04368377 - Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19 Phase 2