Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2
Phase 1
Withdrawn
- Conditions
- Healthy
- Interventions
- Drug: NVP-1603-2 (T)Drug: NVP-1603-1 (P)Drug: NVP-1603-1 and NVP-1603-2 (P+T)
- Registration Number
- NCT03220399
- Lead Sponsor
- NVP Healthcare
- Brief Summary
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
- Detailed Description
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Men 19years of age or older at screening test.
- BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
- Subject has signed and dated informed consent.
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
- Current alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NVP-1603-2(T) NVP-1603-2 (T) Drug: NVP-1603-2 1Tablet, oral dosing NVP-1603-1 (P) NVP-1603-1 (P) Drug: NVP-1603-1 1capsule, oral dosing NVP-1603-1and NVP-1603-2 (P+T) NVP-1603-1 and NVP-1603-2 (P+T) Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)
- Primary Outcome Measures
Name Time Method Pharmacokinetic interaction 0h - 48hrs Area under the curve (AUC)
- Secondary Outcome Measures
Name Time Method