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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05023031
Enrollment
53
Registered
2021-08-26
Start date
2021-10-05
Completion date
2022-01-15
Last updated
2022-01-19

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-2102 and NVP-2102-R.

Detailed description

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

Interventions

DRUGNVP-2102

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

DRUGNVP-2102-R

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

Sponsors

NVP Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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

MeasureTime frameDescription
Evaluation of Area under the plasma drug concentration-time curve(AUCt)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of Maximum observed plasma concentration(Cmax)0 ~ 72 hoursPharmacokinetics parameter derived from plasma

Secondary

MeasureTime frameDescription
Evaluation of Time of peak concentration(Tmax)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of Terminal phase of Half-life(t1/2)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of volume of distribution after non-intravenous administration(Vz/F)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of total clearance of the drug from plasma after oral administration(CL/F)0 ~ 72 hoursPharmacokinetics parameter derived from plasma
Evaluation of AUCt/AUC∞0 ~ 72 hoursPharmacokinetics parameter derived from plasma

Countries

South Korea

Outcome results

None listed

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