Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2

Sponsor

NVP Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT04780386

Collaborator

(none)

Enrollment

Location

Arms

5.6

Actual Duration (Months)

10.3

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	Drug: NVP-1805 Drug: NVP-1805-R1and NVP-1805-R2	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Male Volunteers

Actual Study Start Date :

Aug 29, 2020

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Feb 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-1805 NVP-1805	Drug: NVP-1805 orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
Active Comparator: NVP-1805-R1 and NVP-1805-R2 coadministration of NVP-1805-R1 and NVP-1805-R2	Drug: NVP-1805-R1and NVP-1805-R2 orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)

Arm

Intervention/Treatment

Experimental: NVP-1805

NVP-1805

Drug: NVP-1805

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)

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

coadministration of NVP-1805-R1 and NVP-1805-R2

Drug: NVP-1805-R1and NVP-1805-R2

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of plasma: AUClast [0hours - 72hours]
Pharmacokinetics of plasma: Cmax [0hours - 72hours]

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/㎡ and <30.0 kg/㎡ 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 Hospital	Seoul	Nambusunhwan-ro	Korea, Republic of	08779

Sponsors and Collaborators

NVP Healthcare

Investigators

Principal Investigator: Jaewoo Kim, M.D., H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NVP Healthcare

ClinicalTrials.gov Identifier:

NCT04780386

Other Study ID Numbers:

NVP-1805_BE

First Posted:

Mar 3, 2021

Last Update Posted:

Mar 3, 2021

Last Verified:

Mar 1, 2021

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

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

Study Results

No Results Posted as of Mar 3, 2021