A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

NVP Healthcare1 site in 1 country50 target enrollmentDecember 29, 2021

ConditionsHealthy Subjects

InterventionsNVP-1705 NVP-1705-R

DrugsNVP-1705 NVP-1705-R

Overview

Phase: Phase 1
Intervention: NVP-1705
Conditions: Healthy Subjects
Sponsor: NVP Healthcare
Enrollment: 50
Locations: 1
Primary Endpoint: Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Status: Completed
Last Updated: 3 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-1705 and NVP-1705-R.

Detailed Description

Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Registry

clinicaltrials.gov

Start Date

December 29, 2021

End Date

June 29, 2022

Last Updated

3 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-1705

Tablet formulation for oral administration, single dose of NVP-1705 at Day 1

Intervention: NVP-1705

NVP-1705-R

Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1

Intervention: NVP-1705-R

Outcomes

Primary Outcomes

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

Time Frame: 0 ~ 48 hours

Pharmacokinetics parameter derived from plasma

Evaluation of Maximum observed plasma concentration(Cmax)

Time Frame: 0 ~ 48 hours

Pharmacokinetics parameter derived from plasma

Secondary Outcomes

Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)(0 ~ 48 hours)
Evaluation of AUCt/AUC∞(0 ~ 48 hours)
Evaluation of Time of peak concentration(Tmax)(0 ~ 48 hours)
Evaluation of Terminal phase of Half-life(t1/2)(0 ~ 48 hours)