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NCT05141110 Clinical Trial

Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:
A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05141110
Other study ID # NVP-1705_BE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 29, 2021
Est. completion date June 29, 2022

Study information
Verified date April 2022
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 and safety of NVP-1705 and NVP-1705-R.

Description:

Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 29, 2022
Est. primary completion date April 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Healthy subject, 19 years of age or older - Subjects who signed informed consent - Body mass index(BMI) of 18 to 30.0 kg/? Exclusion Criteria: - Subject who has clinically significant medical history - Inadequate subject for the clinical trial by the investigator's decision - Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-1705
NVP-1705
• NVP-1705-R
NVP-1705-R

Locations
Country Name City State
Korea, Republic of H Plus Yangji Hospital Seoul Nambusunhwan-ro

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 Evaluation of Area under the plasma drug concentration-time curve(AUCt) Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
Primary Evaluation of Maximum observed plasma concentration(Cmax) Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
Secondary Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8) Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
Secondary Evaluation of AUCt/AUC8 Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
Secondary Evaluation of Time of peak concentration(Tmax) Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
Secondary Evaluation of Terminal phase of Half-life(t1/2) Pharmacokinetics parameter derived from plasma 0 ~ 48 hours
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