To Evaluate the Safety and the Pharmacokinetics of NVP-2203

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NVP-2203; Drug: NVP-2203-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT05725252

NVP-2203_BA

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Full description

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult subjects who signed informed consent
• BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion criteria

• Subjects participated in another clinical trial within 6 months prior to administration of the study drug
• Inadequate subject for the clinical trial by the investigator's decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

NVP-2203

Experimental group

Description:

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Treatment:

Drug: NVP-2203

NVP-2203-R

Active Comparator group

Description:

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Treatment:

Drug: NVP-2203-R