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

Sponsor
NVP Healthcare (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05141110
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
single-dose, crossover studysingle-dose, crossover study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 29, 2021
Anticipated Primary Completion Date :
Apr 29, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Area under the plasma drug concentration-time curve(AUCt) [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

  2. Evaluation of Maximum observed plasma concentration(Cmax) [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

Secondary Outcome Measures

  1. Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

  2. Evaluation of AUCt/AUC∞ [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

  3. Evaluation of Time of peak concentration(Tmax) [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

  4. Evaluation of Terminal phase of Half-life(t1/2) [0 ~ 48 hours]

    Pharmacokinetics parameter derived from plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 H Plus Yangji Hospital Seoul Nambusunhwan-ro Korea, Republic of 08779

Sponsors and Collaborators

  • NVP Healthcare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NVP Healthcare
ClinicalTrials.gov Identifier:
NCT05141110
Other Study ID Numbers:
  • NVP-1705_BE
First Posted:
Dec 2, 2021
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 14, 2022