NCT04905342
Completed
Phase 1
An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
NVP Healthcare1 site in 1 country58 target enrollmentAugust 14, 2021
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- NVP-1805
- Conditions
- Healthy Volunteers
- Sponsor
- NVP Healthcare
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of plasma: Cmax
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Detailed Description
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult subjects who signed informed consent
- •BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)
Exclusion Criteria
- •Subjects participated in another clinical trial within 6 months prior to administration of the study drug
- •Inadequate subject for the clinical trial by the investigator's decision
- •Subjects participated in another clinical trial within 6 months prior to administration of the study drug
Arms & Interventions
NVP-1805
NVP-1805 (80/10/20.8mg)
Intervention: NVP-1805
NVP-1805-R1 and NVP-1805-R2
coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)
Intervention: NVP-1805-R1and NVP-1805-R2
Outcomes
Primary Outcomes
Pharmacokinetics of plasma: Cmax
Time Frame: 0hours - 72hours
period 1,2,3,4
Pharmacokinetics of plasma: AUClast
Time Frame: 0hours - 72hours
period 1,2,3,4
Study Sites (1)
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