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

September 27, 2022 updated by: NVP Healthcare

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

The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Nambusunhwan-ro
      • Seoul, Nambusunhwan-ro, Korea, Republic of, 08779
        • H Plus Yangji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVP-1705
Tablet formulation for oral administration, single dose of NVP-1705 at Day 1
Drug: NVP-1705
NVP-1705
Active Comparator: NVP-1705-R
Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1
Drug: NVP-1705-R
NVP-1705-R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours
Evaluation of Maximum observed plasma concentration(Cmax)
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours
Evaluation of AUCt/AUC∞
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours
Evaluation of Time of peak concentration(Tmax)
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours
Evaluation of Terminal phase of Half-life(t1/2)
Time Frame: 0 ~ 48 hours
Pharmacokinetics parameter derived from plasma
0 ~ 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Jae Woo Kim, M.D., Ph.D, H+ Yangji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

November 21, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NVP-1705_BE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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