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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NVP-1805; Drug: NVP-1805-R1and NVP-1805-R2

• Registration Number: NCT04780386
• Lead Sponsor: NVP Healthcare

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.

Detailed Description

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

Study Timeline

• Study Start: 2020-08-29
• Primary Completion: 2020-11-02
• Study Completion: 2021-02-16
• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-1805	NVP-1805	NVP-1805
NVP-1805-R1 and NVP-1805-R2	NVP-1805-R1and NVP-1805-R2	coadministration of NVP-1805-R1 and NVP-1805-R2

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of plasma: AUClast	0hours - 72hours
Pharmacokinetics of plasma: Cmax	0hours - 72hours

Trial Locations

Locations (1)

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