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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Jeonbuk National University Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Subjects does not meet the Inclusion Criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Min-Gul Kim, PI, Jeonbuk National University Hospita

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2022
• Primary Completion (ACTUAL): March 16, 2022
• Study Completion (ACTUAL): March 23, 2022

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JW21101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No