A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

Sponsor

NVP Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT02289404

Collaborator

(none)

Enrollment

Location

Arms

1.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: NVP-1203 Drug: NVP-1203	Phase 1

Detailed Description

This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects

Actual Study Start Date :

Jan 18, 2019

Actual Primary Completion Date :

Jan 27, 2019

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-1203(fed then fasting) 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 Oral
Experimental: NVP-1203(fasting then fed) 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 Oral

Arm

Intervention/Treatment

Experimental: NVP-1203(fed then fasting)

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

Oral

Experimental: NVP-1203(fasting then fed)

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

Oral

Outcome Measures

Primary Outcome Measures

Pharmacokinetics : Cmax [0-24 hours]
Maximum plasma concentration
Pharmacokinetics : AUCt [0-24 hours]
Area under the concentration-time curve

Secondary Outcome Measures

Pharmacokinetics : AUCinf [0-24 hours]
AUC extrapolated to infinity
Pharmacokinetics : Tmax [0-24 hours]
Time to reach the Cmax
Pharmacokinetics : t1/2 [0-24 hours]
Terminal elimination half-life

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy adult subjects who signed informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Hospital	Daegu	Dongdeok-ro	Korea, Republic of	700-721

Sponsors and Collaborators

NVP Healthcare

Investigators

Principal Investigator: Yoon Y Ran, M.D., Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NVP Healthcare

ClinicalTrials.gov Identifier:

NCT02289404

Other Study ID Numbers:

NVP-1203_FE

First Posted:

Nov 13, 2014

Last Update Posted:

Mar 8, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 8, 2019