Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 (Navipharm)

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1203-R1 and NVP-1203-R2; Drug: NVP-1203-R2; Drug: NVP-1203-R1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04181437

NVP-1203_DDI

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Full description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adult subjects who signed informed consent

Exclusion criteria

• Subjects has a history of allergy reaction of study drug ingredient
• 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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40 participants in 3 patient groups

NVP-1203-R1

Experimental group

Description:

Drug: NVP-1203-R1 1 tablet, oral dosing

Treatment:

Drug: NVP-1203-R1

NVP-1203-R2

Experimental group

Description:

Drug: NVP-1203-R2 1 tablet, oral dosing

Treatment:

Drug: NVP-1203-R2

NVP-1203-R1 and NVP-1203-R2

Experimental group

Description:

Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

Treatment:

Drug: NVP-1203-R1 and NVP-1203-R2