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

September 20, 2023 updated by: Hanmi Pharmaceutical Company Limited

An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed Sequence
Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203
Drug: RLD2202
Take it once a day per period
Drug: RLD2203
Take it once a day per period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax,ss of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
t1/2,ss of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
Cmin,ss of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
Cavg,ss of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
CLss/F of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
Vdss/F of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours
PTF of RLD2202 and RLD2203
Time Frame: 0~24 hours
Pharmacokinetic evaluation
0~24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: SeungHwan Lee, M.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

October 25, 2022

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HM-SARA-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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