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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: NVP-2102-R; Drug: NVP-2102

• Registration Number: NCT05023031
• Lead Sponsor: NVP Healthcare

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

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-26
• Study Start: 2021-10-05
• Primary Completion: 2021-12-24
• Status Verified: 2022-01
• Study Completion: 2022-01-15
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-2102-R	NVP-2102-R	NVP-2102-R
NVP-2102	NVP-2102	NVP-2102

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Nambusunhwan-ro, Korea, Republic of