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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023031
• Other study ID #: NVP-2102_BE
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: Navipharm Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 15, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• NVP-2102
Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
• NVP-2102-R
Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul	Nambusunhwan-ro

Sponsors (1)

Lead Sponsor	Collaborator
Navipharm Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Area under the plasma drug concentration-time curve(AUCt)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Primary	Evaluation of Maximum observed plasma concentration(Cmax)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of AUCt/AUC8	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of Time of peak concentration(Tmax)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of Terminal phase of Half-life(t1/2)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of total clearance of the drug from plasma after oral administration(CL/F)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours
Secondary	Evaluation of volume of distribution after non-intravenous administration(Vz/F)	Pharmacokinetics parameter derived from plasma	0 ~ 72 hours