NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)

Sponsor

NVP Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05354713

Collaborator

(none)

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: NVP-1805 Drug: NVP-1805-R1 and NVP-1805-R2	Phase 1

Detailed Description

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Clinical Trial to Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Anticipated Study Start Date :

May 4, 2022

Anticipated Primary Completion Date :

Jun 17, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-1805 orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)	Drug: NVP-1805 NVP-1805 (80/10/20.8mg)
Active Comparator: NVP-1805-R1 and NVP-1805-R2 orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)	Drug: NVP-1805-R1 and NVP-1805-R2 coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

Arm

Intervention/Treatment

Experimental: NVP-1805

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

Drug: NVP-1805

NVP-1805 (80/10/20.8mg)

Active Comparator: NVP-1805-R1 and NVP-1805-R2

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Drug: NVP-1805-R1 and NVP-1805-R2

coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

Outcome Measures

Primary Outcome Measures

NVP-1805's Pharmacokinetics of plasma [0hours - 72hours]
AUCt
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
Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospita	Seoul		Korea, Republic of

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:

NCT05354713

Other Study ID Numbers:

NVP-1805_BE-03

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

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

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

Study Results

No Results Posted as of Apr 29, 2022