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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NVP-1203

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongdeok-ro
    • Daegu, Dongdeok-ro, Korea, Republic of, 700-721
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics : Cmax	Maximum plasma concentration	0-24 hours
Pharmacokinetics : AUCt	Area under the concentration-time curve	0-24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics : AUCinf	AUC extrapolated to infinity	0-24 hours
Pharmacokinetics : Tmax	Time to reach the Cmax	0-24 hours
Pharmacokinetics : t1/2	Terminal elimination half-life	0-24 hours

Collaborators and Investigators

• Sponsor: NVP Healthcare
• Investigators: Principal Investigator: Yoon Y Ran, M.D., Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): January 27, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: November 9, 2014
• First Submitted That Met QC Criteria: November 9, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NVP-1203_FE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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