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NCT05354713 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05354713
Other study ID # NVP-1805_BE-03
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 5, 2022
Est. completion date April 27, 2023

Study information
Verified date May 2023
Source NVP Healthcare
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:

Evaluate 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 April 27, 2023
Est. primary completion date March 20, 2023
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/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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of H Plus Yangji Hospita Seoul

Sponsors (1)
Lead Sponsor Collaborator
NVP Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary NVP-1805's Pharmacokinetics of plasma AUCt 0hours - 72hours
Primary Pharmacokinetics of plasma Cmax 0hours - 72hours
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