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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05023031
Other study ID # NVP-2102_BE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 5, 2021
Est. completion date January 15, 2022

Study information

Verified date January 2022
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 and safety of NVP-2102 and NVP-2102-R.


Description:

Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 15, 2022
Est. primary completion date December 24, 2021
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-2102
Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
NVP-2102-R
Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

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 Evaluation of Area under the plasma drug concentration-time curve(AUCt) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Primary Evaluation of Maximum observed plasma concentration(Cmax) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of AUCt/AUC8 Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of Time of peak concentration(Tmax) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of Terminal phase of Half-life(t1/2) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of total clearance of the drug from plasma after oral administration(CL/F) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
Secondary Evaluation of volume of distribution after non-intravenous administration(Vz/F) Pharmacokinetics parameter derived from plasma 0 ~ 72 hours
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