NCT02289404

Brief Summary

The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

November 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
4.2 years until next milestone

Study Start

First participant enrolled

January 18, 2019

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

9 days

First QC Date

November 9, 2014

Last Update Submit

March 6, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics : Cmax

    Maximum plasma concentration

    0-24 hours

  • Pharmacokinetics : AUCt

    Area under the concentration-time curve

    0-24 hours

Secondary Outcomes (3)

  • Pharmacokinetics : AUCinf

    0-24 hours

  • Pharmacokinetics : Tmax

    0-24 hours

  • Pharmacokinetics : t1/2

    0-24 hours

Study Arms (2)

NVP-1203(fed then fasting)

EXPERIMENTAL

Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2

Drug: NVP-1203

NVP-1203(fasting then fed)

EXPERIMENTAL

Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2

Drug: NVP-1203

Interventions

NVP-1203DRUG

Oral

NVP-1203(fed then fasting)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adult subjects who signed informed consent

You may not qualify if:

  • Subjects has a history of allergy reaction of study drug ingredient
  • Subjects participated in another clinical trial within 3 months prior to administration of the study drug
  • Inadequate subject for the clinical trial by the investigator's decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, Dongdeok-ro, 700-721, South Korea

Location

Study Officials

  • Yoon Y Ran, M.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

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

November 9, 2014

First Posted

November 13, 2014

Study Start

January 18, 2019

Primary Completion

January 27, 2019

Study Completion

February 28, 2019

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)