NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: NVP-1805-R1 and NVP-1805-R2
- Registration Number
- NCT05354713
- Lead Sponsor
- NVP Healthcare
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Healthy adult subjects who signed informed consent
- BMI of >18.0 kg/m2 and <30.0 kg/m2 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NVP-1805 NVP-1805 orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg) NVP-1805-R1 and NVP-1805-R2 NVP-1805-R1 and NVP-1805-R2 orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)
- Primary Outcome Measures
Name Time Method NVP-1805's Pharmacokinetics of plasma 0hours - 72hours AUCt
Pharmacokinetics of plasma 0hours - 72hours Cmax
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H Plus Yangji Hospita
🇰🇷Seoul, Korea, Republic of