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Completed

NCT Number: NCT05023031

Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

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Key information

Conditions

Healthy Subjects

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, 08779, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVP-2102

Drug

Tablet formulation for oral administration, single dose of NVP-2102 at Day 1

NVP-2102-R

Drug

Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

Primary outcomes

  1. Evaluation of Area under the plasma drug concentration-time curve(AUCt)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  2. Evaluation of Maximum observed plasma concentration(Cmax)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

Secondary outcomes

  1. Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  2. Evaluation of AUCt/AUC∞

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  3. Evaluation of Time of peak concentration(Tmax)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  4. Evaluation of Terminal phase of Half-life(t1/2)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  5. Evaluation of total clearance of the drug from plasma after oral administration(CL/F)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

  6. Evaluation of volume of distribution after non-intravenous administration(Vz/F)

    Time frame: 0 ~ 72 hours

    Pharmacokinetics parameter derived from plasma

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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