Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NVP-2002-R1+NVP-2002-R2; Drug: NVP-2002

• Registration Number: NCT04961905
• Lead Sponsor: NVP Healthcare

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.

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-14
• Study Start: 2022-09-03
• Primary Completion: 2023-04-25
• Study Completion: 2023-05-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single tablet fist, fed	NVP-2002-R1+NVP-2002-R2	single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition
FDC fist, fed	NVP-2002	NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition
Single tablet fist, fasted	NVP-2002-R1+NVP-2002-R2	single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition
FDC fist, fasted	NVP-2002	NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jeonbuk national university hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of