Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04961905

Enrollment

Registered

2021-07-14

Start date

2022-09-03

Completion date

2023-05-30

Last updated

2023-10-05

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 compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Detailed description

Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.

Interventions

DRUGNVP-2002-R1+NVP-2002-R2

NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily

DRUGNVP-2002

NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\_R2 NVP-2002, 1 tablet, once daily

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 * Body Mass Index(BMI)=18.5\ 29.9kg/㎡

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 * Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of plasma: Cmax	0hours - 72hours	Cmax of NVP-2002-R1 and NVP-2002-R2
Pharmacokinetics of plasma: AUCt	0hours - 72hours	Area under the curve of NVP-2002-R1 and NVP-2002-R2

Countries

South Korea

Outcome results

None listed

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