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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05463497
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 18.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trialA randomized, open-label, multiple-dose, 2x3 crossover clinical trial
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Jan 17, 2022
• Actual Primary Completion Date: Mar 16, 2022
• Actual Study Completion Date: Mar 23, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax,ss [up to 12hour(or 24hour) after administration]

   Cmax,ss of each drug

2. AUCτ,ss [up to 12hour(or 24hour) after administration]

   AUCτ,ss of each drug

Secondary Outcome Measures

1. Cmin,ss [up to 12hour(or 24hour) after administration]

   Cmin,ss of each drug

2. Tmax,ss [up to 12hour(or 24hour) after administration]

   Tmax,ss of each drug

3. CLss/F [up to 12hour(or 24hour) after administration]

   CLss/F of each drug

4. Vdss/F [up to 12hour(or 24hour) after administration]

   Vdss/F of each drug

5. fluctuation [up to 12hour(or 24hour) after administration]

   fluctuation of each drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Subjects does not meet the Inclusion Criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeonbuk National University Hospita	Jeonju	Jeollabuk-do	Korea, Republic of	54907

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

• Principal Investigator: Min-Gul Kim, PI, Jeonbuk National University Hospita

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05463497
• Other Study ID Numbers: JW21101
• First Posted: Jul 19, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 19, 2022