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NCT04780386 Clinical Trial

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

Healthy Clinical Trial

— NVP-1805  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04780386
Other study ID # NVP-1805_BE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 29, 2020
Est. completion date February 16, 2021

Study information
Verified date March 2021
Source Navipharm Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date February 16, 2021
Est. primary completion date November 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-1805
orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
• NVP-1805-R1and NVP-1805-R2
orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)

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 Pharmacokinetics of plasma: AUClast 0hours - 72hours
Primary Pharmacokinetics of plasma: Cmax 0hours - 72hours
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