Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-2002; Drug: NVP-2002-R1+NVP-2002-R2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04961905

NVP-2002_BA

Details and patient eligibility

About

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Full description

Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.

Enrollment: 96 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adult subjects who signed informed consent
• Body Mass Index(BMI)=18.5~29.9kg/㎡

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
• Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Single tablet fist, fasted

Experimental group

Description:

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Treatment:

Drug: NVP-2002-R1+NVP-2002-R2

FDC fist, fasted

Experimental group

Description:

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Treatment:

Drug: NVP-2002

Single tablet fist, fed

Experimental group

Description:

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Treatment:

Drug: NVP-2002-R1+NVP-2002-R2

FDC fist, fed

Experimental group

Description:

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Treatment:

Drug: NVP-2002