A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- NVP-1402
- Conditions
- Healthy
- Sponsor
- NVP Healthcare
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of plasma: Cmax
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.
Detailed Description
This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males
- •No history of clinically significant medical disorder
- •Capable of consent to participate in the study
Exclusion Criteria
- •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
Arms & Interventions
NVP-1402
NVP-1402 was administered once a day for 24 hours
Intervention: NVP-1402
NVP-1402R
Active comparator was administered twice a day for 24 hours
Intervention: NVP-1402R
Outcomes
Primary Outcomes
Pharmacokinetics of plasma: Cmax
Time Frame: up to 24 hours after administration
Maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: AUClast
Time Frame: up to 24 hours after administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Secondary Outcomes
- Pharmacokinetics of plasma: AUCinf(up to 24 hours after administration)
- Pharmacokinetics of plasma: Tmax(up to 24 hours after administration)
- Pharmacokinetics of plasma: t1/2(up to 24 hours after administration)