Status:
COMPLETED
The Food Effect on the Pharmacokinetics of NVP-1402
Lead Sponsor:
NVP Healthcare
Conditions:
Healthy
Eligibility:
MALE
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.
Detailed Description
This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetic...
Eligibility Criteria
Inclusion
- Healthy males
- No history of clinically significant medical disorder
- Capable of consent to participate in the study
Exclusion
- History of hypersensitive reactions to study drug or other related drugs
- Any significant abnormality found during screening
- Any significant medical history
- History of alcohol abuse, smoking continuously
- History of drug abuse
- Clinically significant surgery within 4 weeks prior to administration of the study drug
- Participation in another clinical trial within 3 months prior to administration of the study drug
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03340480
Start Date
December 12 2017
End Date
May 2 2018
Last Update
May 17 2018
Active Locations (1)
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1
Navipharm
Suwon, Gyeonggi-do, South Korea, 16209