A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Treatment A_Period 1
- Conditions
- Healthy
- Sponsor
- JW Pharmaceutical
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- AUCt
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.
Detailed Description
Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
Exclusion Criteria
- •Subjects does not meet the inclusion Criteria
Arms & Interventions
Group 1
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment A_Period 1
Group 1
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment B_Period 2
Group 1
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment A_Period 3
Group 1
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment B_Period 4
Group 2
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment B_Period 1
Group 2
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment A_Period 2
Group 2
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment B_Period 3
Group 2
* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Intervention: Treatment A_Period 4
Outcomes
Primary Outcomes
AUCt
Time Frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
Cmax
Time Frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.