A Study to Evaluate the Drug-drug Interaction and Safety... | NCT05862090

Studies
A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

NCT05862090

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

RLD2301
RLD2007

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

Apr 5, 2023Actual

Primary Completion Date

May 26, 2023Actual

Completion Date

May 26, 2023Actual

First Submitted Date

May 8, 2023

First Submission Date that Met QC Criteria

May 8, 2023

First Posted Date

May 17, 2023Actual

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 the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 (First RLD2301, then RLD2301+RLD2007)	Experimental	Period1 : RLD2301 Period2 : RLD2301 + RLD2007	Drug: RLD2301 Drug: RLD2007
Arm 2 (First RLD2007, then RLD2301+RLD2007)	Experimental	Period1 : RLD2007 Period2 : RLD2301 + RLD2007	Drug: RLD2301 Drug: RLD2007

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RLD2301	Drug	Take it once a day per period.	Arm 1 (First RLD2301, then RLD2301+RLD2007) Arm 2 (First RLD2007, then RLD2301+RLD2007)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCtau	Pharmacokinetic evaluation	0~24 hours after final dose administration
Css,max	Pharmacokinetic evaluation	0~24 hours after final dose administration

Secondary Outcomes

Measure	Description	Time Frame
Css,min	Pharmacokinetic evaluation	0~24 hours after final dose administration
Css,av	Pharmacokinetic evaluation	0~24 hours after final dose administration

Other Outcomes

Measure	Description	Time Frame
Change of Blood Pressure(SBP/DBP) from baseline	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Change of pulse rate from baseline	Pharmacodynamic evaluation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 19~54 years in healthy volunteers
18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

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
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

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min-gul Kim, MD	Jeonbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeonbuk University Hospital		Jeonju	Jeollabuk-do		South Korea