To Evaluate the Safety and the Pharmacokinetics of NVP-2203

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05725252

Enrollment

Registered

2023-02-13

Start date

2023-05-28

Completion date

2023-07-05

Last updated

2024-01-11

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

Conditions

Healthy Volunteers

Brief summary

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Detailed description

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Interventions

DRUGNVP-2203

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

DRUGNVP-2203-R

administration of active comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult subjects who signed informed consent * BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion criteria

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug * Inadequate subject for the clinical trial by the investigator's decision

Design outcomes

Primary

Measure	Time frame	Description
NVP-2203's pharmacokinetics of plasma	0hours - 72hours	AUCt

Secondary

Measure	Time frame	Description
pharmacokinetics of plasma	0hours - 72hours	Cmax

Countries

South Korea

Outcome results

None listed

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