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

NVP Healthcare1 site in 1 country96 target enrollmentSeptember 3, 2022

ConditionsHealthy

InterventionsNVP-2002-R1+NVP-2002-R2 NVP-2002

DrugsNVP-2002-R1+NVP-2002-R2 NVP-2002

Overview

Phase: Phase 1
Intervention: NVP-2002-R1+NVP-2002-R2
Conditions: Healthy
Sponsor: NVP Healthcare
Enrollment: 96
Locations: 1
Primary Endpoint: Pharmacokinetics of plasma: Cmax
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 3, 2022

End Date

May 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

NVP Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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