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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Clinical Trial Center, Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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)
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 |
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 |
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 |
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 |
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 |
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 |
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
Time Frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
|
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
Time Frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
|
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
Investigators
- Principal Investigator: MinSoo Kim, Severance Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.