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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RLD2202; Drug: RLD2203

• Registration Number: NCT05481307
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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 available

Study Timeline

• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Study Start: 2022-08-02
• Primary Completion: 2022-10-25
• Study Completion: 2022-10-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Fixed Sequence	RLD2202	Period 1: RLD2202, Period 2 : RLD2203 -\> RLD2202+RLD2203
Fixed Sequence	RLD2203	Period 1: RLD2202, Period 2 : RLD2203 -\> RLD2202+RLD2203

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CLss/F of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
t1/2,ss of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
Cmin,ss of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
Cavg,ss of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
Vdss/F of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
PTF of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation
Tmax,ss of RLD2202 and RLD2203	0~24 hours	Pharmacokinetic evaluation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of