Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

Phase 1WithdrawnNCT03220399

NVP Healthcare

Overview

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy

Interventions

NVP-1603-1 (P)DRUG

1capsule, single oral dosing

NVP-1603-2 (T)DRUG

1tablet, single oral dosing

NVP-1603-1 and NVP-1603-2 (P+T)DRUG

1capsule and 1tablet co-administration, oral single dosing

Eligibility

Sex: MALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men 19years of age or older at screening test. * BMI of \>18.5kg/㎡ and \<27.0kg/㎡ subject, weight more than 50kg. * Subject has signed and dated informed consent. 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 * Current alcohol abuse.

Outcomes

Primary Outcomes

Pharmacokinetic interaction

Area under the curve (AUC)

Time frame: 0h - 48hrs

Data from ClinicalTrials.gov

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