Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT03802526
- Lead Sponsor
- NVP Healthcare
- Brief Summary
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
- Detailed Description
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Male or female adults aged 19-45 years.
- BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
- Voluntarily provided a witten consent to participate in this clinical study.
Exclusion Criteria
- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- Pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NVP-1805-R1 NVP-1805-R1 Drug: NVP-1805-R1 1 tablet, oral dosing NVP-1805-R2 NVP-1805-R2 Drug: NVP-1805-R2 1 tablet, oral dosing NVP-1805-R1 and NVP-1805-R2 NVP-1805-R1 and NVP-1805-R2 Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)
- Primary Outcome Measures
Name Time Method Pharmacokinetic interaction 0hours - 48hours Area under the curve (AUC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Navipharm
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of