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

NVP Healthcare

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1603-1 (P); Drug: NVP-1603-2 (T); Drug: NVP-1603-1 and NVP-1603-2 (P+T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220399

NVP-1603_P1_DDI

Details and patient eligibility

About

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

Full description

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

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

NVP-1603-1 (P)

Experimental group

Description:

Drug: NVP-1603-1 1capsule, oral dosing

Treatment:

Drug: NVP-1603-1 (P)

NVP-1603-2(T)

Experimental group

Description:

Drug: NVP-1603-2 1Tablet, oral dosing

Treatment:

Drug: NVP-1603-2 (T)

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

Experimental group

Description:

Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)

Treatment:

Drug: NVP-1603-1 and NVP-1603-2 (P+T)