To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- Drug: Reference Drug or Test Drug
- Registration Number
- NCT06361277
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions
- Detailed Description
Pharmacokinetic characteristics: 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
- 56
- Healthy volunteers
- Subjects does not meet the Inclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 Reference Drug or Test Drug Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration Group 2 Reference Drug or Test Drug Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
- Primary Outcome Measures
Name Time Method AUCt Day1 0h ~ Day3 48h Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Cmax Day1 0h ~ Day3 48h 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, Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of