A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203
- Registration Number
- NCT02289404
- Lead Sponsor
- NVP Healthcare
- Brief Summary
The purpose of this study is to evaluate food effect on the pharmacokinetics of 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NVP-1203(fed then fasting) NVP-1203 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 NVP-1203(fasting then fed) NVP-1203 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
- Primary Outcome Measures
Name Time Method Pharmacokinetics : Cmax 0-24 hours Maximum plasma concentration
Pharmacokinetics : AUCt 0-24 hours Area under the concentration-time curve
- Secondary Outcome Measures
Name Time Method Pharmacokinetics : AUCinf 0-24 hours AUC extrapolated to infinity
Pharmacokinetics : t1/2 0-24 hours Terminal elimination half-life
Pharmacokinetics : Tmax 0-24 hours Time to reach the Cmax
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Daegu, Dongdeok-ro, Korea, Republic of