NCT03220399

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Typical duration for phase_1 healthy

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

June 30, 2017

Last Update Submit

August 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic interaction

    Area under the curve (AUC)

    0h - 48hrs

Study Arms (3)

NVP-1603-1 (P)

EXPERIMENTAL

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

Drug: NVP-1603-1 (P)

NVP-1603-2(T)

EXPERIMENTAL

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

Drug: NVP-1603-2 (T)

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

EXPERIMENTAL

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

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

Interventions

NVP-1603-1 (P)DRUG

1capsule, single oral dosing

Also known as: NVP-1603-1
NVP-1603-1 (P)
NVP-1603-2 (T)DRUG

1tablet, single oral dosing

Also known as: NVP-1603-2
NVP-1603-2(T)
NVP-1603-1 and NVP-1603-2 (P+T)DRUG

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

Also known as: NVP-1603-1 and NVP-1603-2
NVP-1603-1and NVP-1603-2 (P+T)

Eligibility Criteria

Age19 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy males (19years of age or older)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 18, 2017

Study Start

December 1, 2019

Primary Completion

March 28, 2020

Study Completion

July 31, 2020

Last Updated

August 26, 2019

Record last verified: 2019-08