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CompletedNCT05141110Updated Sep 29, 2022

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

A Phase 1 interventional study of NVP-1705 and NVP-1705-R in Healthy Subjects, sponsored by NVP Healthcare. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.

Sponsored by NVP Healthcare · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

NVP Healthcare is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    NVP-1705

    Tablet formulation for oral administration, single dose of NVP-1705 at Day 1

    Drug: 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

Interventions

  • DrugNVP-1705

    NVP-1705

  • DrugNVP-1705-R

    NVP-1705-R

06

What researchers measure

Primary outcomes

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

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

  2. Evaluation of Maximum observed plasma concentration(Cmax)

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

Secondary outcomes

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

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

  2. Evaluation of AUCt/AUC∞

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

  3. Evaluation of Time of peak concentration(Tmax)

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

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

    Pharmacokinetics parameter derived from plasma

    Time frame: 0 ~ 48 hours

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, Nambusunhwan-ro 08779, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05141110
Lead sponsor
NVP Healthcare
Responsible party
Sponsor
First posted
Dec 2, 2021
Start date
Dec 29, 2021
Primary completion
Apr 27, 2022
Completion
Jun 29, 2022
Last update
Sep 29, 2022

Study contacts

Jae Woo Kim, M.D., Ph.D
principal investigator · H+ Yangji hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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