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

NVP Healthcare1 site in 1 country53 target enrollmentOctober 5, 2021

ConditionsHealthy Subjects

InterventionsNVP-2102 NVP-2102-R

DrugsNVP-2102 NVP-2102-R

Overview

Phase: Phase 1
Intervention: NVP-2102
Conditions: Healthy Subjects
Sponsor: NVP Healthcare
Enrollment: 53
Locations: 1
Primary Endpoint: Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 5, 2021

End Date

January 15, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

NVP Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

NVP-2102

Intervention: NVP-2102

NVP-2102-R

Intervention: NVP-2102-R

Outcomes

Primary Outcomes

Evaluation of Area under the plasma drug concentration-time curve(AUCt)

Time Frame: 0 ~ 72 hours

Pharmacokinetics parameter derived from plasma

Evaluation of Maximum observed plasma concentration(Cmax)

Time Frame: 0 ~ 72 hours

Pharmacokinetics parameter derived from plasma

Secondary Outcomes

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