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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05481307
Enrollment
24
Registered
2022-08-01
Start date
2022-08-02
Completion date
2022-10-25
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGRLD2202

Take it once a day per period

DRUGRLD2203

Take it once a day per period

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Cmax,ss of RLD22020~24 hoursPharmacokinetic evaluation
AUCtau,ss of RLD22020~24 hoursPharmacokinetic evaluation
Cmax,ss of RLD22030~24 hoursPharmacokinetic evaluation
AUCtau,ss of RLD22030~24 hoursPharmacokinetic evaluation
Inhibition of Platelet Aggregation(%)0~6 daysPharmacodynamic evaluation
Inhibition of Thromboxane B2(%)0~6 daysPharmacodynamic evaluation

Secondary

MeasureTime frameDescription
Tmax,ss of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
PTF of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
t1/2,ss of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
Cmin,ss of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
Cavg,ss of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
CLss/F of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation
Vdss/F of RLD2202 and RLD22030~24 hoursPharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026