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Completed

NCT Number: NCT05128591

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

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

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Key information

Conditions

Embolism and Thrombosis Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

H+ Yangji Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban 18mg Oral Tablet

Drug

AD-109 (Rivaroxaban 18mg) Oral Tablet

Rivaroxaban 20 MG Oral Tablet

Drug

AD-1091 (Rivaroxaban 20mg) Oral Tablet

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: pre-dose to 34 hours

    Cmax of Rivaroxaban

  2. Area Under the Curve in time plot (AUCt)

    Time frame: pre-dose to 34 hours

    AUCt of Rivaroxaban

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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