To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers
- Conditions
- Healthy
- Registration Number
- NCT06378684
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers
- Detailed Description
Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Healthy volunteers
- Subjects does not meet the Inclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Cmax,ss Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours) Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
AUCτ,ss Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours) Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial Center, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Clinical Trial Center, Severance Hospital🇰🇷Seoul, Korea, Republic of