Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1805-R2; Drug: NVP-1805-R1 and NVP-1805-R2; Drug: NVP-1805-R1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802526

NVP-1805_DDI

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Full description

pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Enrollment: 37 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults aged 19-45 years.
• BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
• Voluntarily provided a witten consent to participate in this clinical study.

Exclusion criteria

• Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
• History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

NVP-1805-R1

Experimental group

Description:

Drug: NVP-1805-R1 1 tablet, oral dosing

Treatment:

Drug: NVP-1805-R1

NVP-1805-R2

Experimental group

Description:

Drug: NVP-1805-R2 1 tablet, oral dosing

Treatment:

Drug: NVP-1805-R2

NVP-1805-R1 and NVP-1805-R2

Experimental group

Description:

Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)

Treatment:

Drug: NVP-1805-R1 and NVP-1805-R2