To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment D
* Drug: Treatment E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria: Subjects does not meet the Inclusion Criteria

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1(N=10)<br>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 | Drug: Treatment A<br>* JW0201: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment B<br>* C2103: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment C<br>* JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days<br>|
| Other: Group 2(N=10)<br>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 | Drug: Treatment A<br>* JW0201: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment B<br>* C2103: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment C<br>* JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days<br>|
| Other: Group 3(N=10)<br>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 | Drug: Treatment A<br>* JW0201: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment D<br>* C2104 : single administration, Tablet, Oral, QD for 5 days<br>Drug: Treatment E<br>* JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days<br>|
| Other: Group 4(N=10)<br>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 | Drug: Treatment A<br>* JW0201: single administration, Tablet, Oral, BID for 5 days<br>Drug: Treatment D<br>* C2104 : single administration, Tablet, Oral, QD for 5 days<br>Drug: Treatment E<br>* JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss | Cmax,ss of each drug | up to 12hour(or 24hour) after administration | 
| AUCτ,ss | AUCτ,ss of each drug | up to 12hour(or 24hour) after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin,ss | Cmin,ss of each drug | up to 12hour(or 24hour) after administration | 
| Tmax,ss | Tmax,ss of each drug | up to 12hour(or 24hour) after administration | 
| CLss/F | CLss/F of each drug | up to 12hour(or 24hour) after administration | 
| Vdss/F | Vdss/F of each drug | up to 12hour(or 24hour) after administration | 
| fluctuation | fluctuation of each drug | up to 12hour(or 24hour) after administration |