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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-01-15

Brief Summary

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

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Detailed Description

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

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVP-2102

Group Type EXPERIMENTAL

NVP-2102

Intervention Type DRUG

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

NVP-2102-R

Group Type ACTIVE_COMPARATOR

NVP-2102-R

Intervention Type DRUG

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

Interventions

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NVP-2102

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

Intervention Type DRUG

NVP-2102-R

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes