To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
NCT ID: NCT05463497
Last Updated: 2022-07-19
Study Results
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Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2022-01-17
2022-03-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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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
Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment B
C2103: single administration, Tablet, Oral, BID for 5 days
Treatment C
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
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
Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment B
C2103: single administration, Tablet, Oral, BID for 5 days
Treatment C
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
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
Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment D
C2104 : single administration, Tablet, Oral, QD for 5 days
Treatment E
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days
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
Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment D
C2104 : single administration, Tablet, Oral, QD for 5 days
Treatment E
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days
Interventions
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Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment B
C2103: single administration, Tablet, Oral, BID for 5 days
Treatment C
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
Treatment D
C2104 : single administration, Tablet, Oral, QD for 5 days
Treatment E
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days
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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Min-Gul Kim, PI
Role: PRINCIPAL_INVESTIGATOR
Jeonbuk National University Hospita
Locations
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Jeonbuk National University Hospita
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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JW21101
Identifier Type: -
Identifier Source: org_study_id
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