To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3); Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3); Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3); Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3); Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3); Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)

Detailed Description

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical Trial Center, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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 Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Other: Group 2; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Other: Group 3; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Other: Group 4; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Other: Group 5; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Other: Group 6; Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3); Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss	Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.	Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
AUCτ,ss	Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.	Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: MinSoo Kim, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Actual): December 23, 2023
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JW22105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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