A Study to Compare Pharmacokinetic Parameters and Safety... | NCT05128591

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

NCT05128591

Sponsor

Addpharma Inc.

Status

Completed

Last Update Posted

Mar 8, 2022Actual

Enrollment

38Actual

Phase

Phase 1

Conditions

Embolism and Thrombosis

Interventions

Rivaroxaban 18mg Oral Tablet
Rivaroxaban 20 MG Oral Tablet

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Nov 10, 2021

First Submission Date that Met QC Criteria

Nov 10, 2021

First Posted Date

Nov 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2022

Last Update Posted Date

Mar 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A-Rivaroxaban	Experimental	Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)	Drug: Rivaroxaban 18mg Oral Tablet Drug: 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 Tablet Drug: Rivaroxaban 20 MG Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban 18mg Oral Tablet	Drug	AD-109 (Rivaroxaban 18mg) Oral Tablet	Arm A-Rivaroxaban Arm B-Rivaroxaban

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016769	Embolism and Thrombosis

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban
D013607	Tablets

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

Browse Leaves

Not provided

Browse Branches

Not provided