Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects

A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: NVP-2102; Drug: NVP-2102-R

Detailed Description

Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nambusunhwan-ro
    • Seoul, Nambusunhwan-ro, Korea, Republic of, 08779
      • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy subject, 19 years of age or older
• Subjects who signed informed consent
• Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion Criteria:

• Subject who has clinically significant medical history
• Inadequate subject for the clinical trial by the investigator's decision
• Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVP-2102	Drug: NVP-2102; Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
Active Comparator: NVP-2102-R	Drug: NVP-2102-R; Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Area under the plasma drug concentration-time curve(AUCt)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of Maximum observed plasma concentration(Cmax)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of AUCt/AUC∞	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of Time of peak concentration(Tmax)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of Terminal phase of Half-life(t1/2)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of total clearance of the drug from plasma after oral administration(CL/F)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Evaluation of volume of distribution after non-intravenous administration(Vz/F)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours

Collaborators and Investigators

• Sponsor: NVP Healthcare
• Investigators: Principal Investigator: Jae Woo Kim, H+ Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NVP-2102_BE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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