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

Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers

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

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: NVP-1603-1 (P); Drug: NVP-1603-2 (T); Drug: NVP-1603-1 and NVP-1603-2 (P+T)

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVP-1603-1 (P); Drug: NVP-1603-1 1capsule, oral dosing	Drug: NVP-1603-1 (P); 1capsule, single oral dosing; Other Names: NVP-1603-1
Experimental: NVP-1603-2(T); Drug: NVP-1603-2 1Tablet, oral dosing	Drug: NVP-1603-2 (T); 1tablet, single oral dosing; Other Names: NVP-1603-2
Experimental: NVP-1603-1and NVP-1603-2 (P+T); Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)	Drug: NVP-1603-1 and NVP-1603-2 (P+T); 1capsule and 1tablet co-administration, oral single dosing; Other Names: NVP-1603-1 and NVP-1603-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic interaction	Area under the curve (AUC)	0h - 48hrs

Collaborators and Investigators

• Sponsor: NVP Healthcare

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): March 28, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NVP-1603_P1_DDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No