To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers
NCT ID: NCT06378684
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2023-09-10
2024-01-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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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
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
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
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
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
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
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
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
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
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
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
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
Interventions
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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
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
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
19 Years
55 Years
ALL
Yes
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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MinSoo Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Clinical Trial Center, Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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JW22105
Identifier Type: -
Identifier Source: org_study_id
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