To Evaluate the Safety and the Pharmacokinetics of NVP-2203

Sponsor

NVP Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05725252

Collaborator

(none)

Enrollment

Location

Arms

4.1

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: NVP-2203 Drug: NVP-2203-R	Phase 1

Detailed Description

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers

Anticipated Study Start Date :

May 28, 2023

Anticipated Primary Completion Date :

Jun 11, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-2203 After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)	Drug: NVP-2203 NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)
Active Comparator: NVP-2203-R After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)	Drug: NVP-2203-R administration of active comparator

Arm

Intervention/Treatment

Experimental: NVP-2203

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Drug: NVP-2203

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

Active Comparator: NVP-2203-R

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Drug: NVP-2203-R

administration of active comparator

Outcome Measures

Primary Outcome Measures

NVP-2203's pharmacokinetics of plasma [0hours - 72hours]
AUCt

Secondary Outcome Measures

pharmacokinetics of plasma [0hours - 72hours]
Cmax

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adult subjects who signed informed consent
BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

Subjects participated in another clinical trial within 6 months prior to administration of the study drug
Inadequate subject for the clinical trial by the investigator's decision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospital	Seoul	Nambusunhwan-ro	Korea, Republic of	08779

Sponsors and Collaborators

NVP Healthcare

Investigators

Principal Investigator: Jaewoo Kim, H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NVP Healthcare

ClinicalTrials.gov Identifier:

NCT05725252

Other Study ID Numbers:

NVP-2203_BA

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 17, 2023