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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NVP-2002-R1+NVP-2002-R2; Drug: NVP-2002

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single tablet fist, fasted; single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition	Drug: NVP-2002-R1+NVP-2002-R2; NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily
Experimental: FDC fist, fasted; NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition	Drug: NVP-2002; NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily
Experimental: Single tablet fist, fed; single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition	Drug: NVP-2002-R1+NVP-2002-R2; NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily
Experimental: FDC fist, fed; NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition	Drug: NVP-2002; NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NVP Healthcare
• Investigators: Principal Investigator: Min-Gul Kim, M.D., Ph.D, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NVP-2002_BA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No