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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05141110

Enrollment

Registered

2021-12-02

Start date

2021-12-29

Completion date

2022-06-29

Last updated

2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Detailed description

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

Interventions

DRUGNVP-1705

NVP-1705

DRUGNVP-1705-R

NVP-1705-R

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

single-dose, crossover study

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026