A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-... | NCT05481307

Studies
A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

NCT05481307

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

RLD2202
RLD2203

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

Sep 2023

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

Aug 2, 2022Actual

Primary Completion Date

Oct 25, 2022Actual

Completion Date

Oct 25, 2022Actual

First Submitted Date

Jul 29, 2022

First Submission Date that Met QC Criteria

Jul 29, 2022

First Posted Date

Aug 1, 2022Actual

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

Sep 20, 2023

Last Update Posted Date

Sep 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects

Detailed Description

Not provided

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fixed Sequence	Experimental	Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203	Drug: RLD2202 Drug: RLD2203

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RLD2202	Drug	Take it once a day per period	Fixed Sequence
RLD2203

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax,ss of RLD2202	Pharmacokinetic evaluation	0~24 hours
AUCtau,ss of RLD2202	Pharmacokinetic evaluation	0~24 hours
Cmax,ss of RLD2203	Pharmacokinetic evaluation	0~24 hours
AUCtau,ss of RLD2203	Pharmacokinetic evaluation	0~24 hours
Inhibition of Platelet Aggregation(%)	Pharmacodynamic evaluation	0~6 days
Inhibition of Thromboxane B2(%)	Pharmacodynamic evaluation	0~6 days

Secondary Outcomes

Measure	Description	Time Frame
Tmax,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
t1/2,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:
1. Healthy adults in the age between 19 and 50 years old
2. Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
3. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
4. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Exclusion Criteria:
1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SeungHwan Lee, M.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea