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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481307
• Other study ID #: HM-SARA-101
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2022
• Est. completion date: October 25, 2022

Study information

• Verified date: September 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RLD2202
Take it once a day per period
• RLD2203
Take it once a day per period

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss of RLD2202	Pharmacokinetic evaluation	0~24 hours
Primary	AUCtau,ss of RLD2202	Pharmacokinetic evaluation	0~24 hours
Primary	Cmax,ss of RLD2203	Pharmacokinetic evaluation	0~24 hours
Primary	AUCtau,ss of RLD2203	Pharmacokinetic evaluation	0~24 hours
Primary	Inhibition of Platelet Aggregation(%)	Pharmacodynamic evaluation	0~6 days
Primary	Inhibition of Thromboxane B2(%)	Pharmacodynamic evaluation	0~6 days
Secondary	Tmax,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	t1/2,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	Cmin,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	Cavg,ss of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	CLss/F of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	Vdss/F of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours
Secondary	PTF of RLD2202 and RLD2203	Pharmacokinetic evaluation	0~24 hours