Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961905
• Other study ID #: NVP-2002_BA
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2023
• Source: NVP Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 30, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NVP-2002-R1+NVP-2002-R2
NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily
• NVP-2002
NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk national university hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
NVP Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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