To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05463497
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults
- Detailed Description
1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Healthy volunteers
Exclusion Criteria
- Subjects does not meet the Inclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1(N=10) Treatment B Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 1(N=10) Treatment C Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 3(N=10) Treatment E Treatment A for Period I Treatment E Treatment D \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 4(N=10) Treatment A Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Group 1(N=10) Treatment A Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 3(N=10) Treatment A Treatment A for Period I Treatment E Treatment D \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 4(N=10) Treatment E Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Group 3(N=10) Treatment D Treatment A for Period I Treatment E Treatment D \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Group 2(N=10) Treatment A Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Group 2(N=10) Treatment B Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Group 2(N=10) Treatment C Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Group 4(N=10) Treatment D Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
- Primary Outcome Measures
Name Time Method Cmax,ss up to 12hour(or 24hour) after administration Cmax,ss of each drug
AUCτ,ss up to 12hour(or 24hour) after administration AUCτ,ss of each drug
- Secondary Outcome Measures
Name Time Method Tmax,ss up to 12hour(or 24hour) after administration Tmax,ss of each drug
Vdss/F up to 12hour(or 24hour) after administration Vdss/F of each drug
Cmin,ss up to 12hour(or 24hour) after administration Cmin,ss of each drug
CLss/F up to 12hour(or 24hour) after administration CLss/F of each drug
fluctuation up to 12hour(or 24hour) after administration fluctuation of each drug
Trial Locations
- Locations (1)
Jeonbuk National University Hospita
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of