Status Approved
First Submitted Date
2014/11/20
Registered Date
2014/12/05
Last Updated Date
2014/12/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001299 |
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Unique Protocol ID | MI-04-02 |
Public/Brief Title | Bioavailability and Pharmacodynamic study of Disgren EC capsule(Triflusal 300mg) |
Scientific Title | Bioavailability and Pharmacodynamic study (phase1) of Disgren EC capsule(Triflusal 300mg) |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KNUH_07-0047 |
Approval Date | 2007-11-19 |
Institutional Review Board Name | Kyungpook National University Hospital Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young-Ran Yoon |
Title | Professor |
Telephone | +82-53-420-4950 |
Affiliation | Kyungpook National University Hospital |
Address | |
Contact Person for Public Queries | |
Name | Young-Ran Yoon |
Title | Professor |
Telephone | +82-53-420-4950 |
Affiliation | Kyungpook National University Hospital |
Address | |
Contact Person for Updating Information | |
Name | Young-Ran Yoon |
Title | Professor |
Telephone | +82-53-420-4950 |
Affiliation | Kyungpook National University Hospital |
Address |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2008-09-19 Actual | |
Target Number of Participant | 38 | |
Primary Completion Date | 2008-10-25 , Actual | |
Study Completion Date | 2008-11-04 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyungpook National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2008-09-19 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Myungin Pharm |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyungpook National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | A randomized, open-label, multiple-dose, two-period, two-treatment, comparative crossover study involving 38 healthy adult males. The clinical trial was to determine the bioequivalence and non-inferiority of two different triflusal formulations. During each period, each subject received a single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Basic Science |
Phase | Phase1 |
Intervention Model | Cross-over |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | Triflusal capsule (Disgren capsule, 300 mg), as the reference formulation, and triflusal EC capsule (Disgren enteric-coated capsule, 300 mg), as the test formulation were manufactured and provided by Myung-In Pharm. Co., Ltd (Seoul, Republic of Korea). The subjects received the test or reference formulation in multiple doses, followed by a 13-day washout period and subsequent administration of the alternative formulation. During each period, each subject received a single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. |
Number of Arms | 2 |
Arm 1 |
Arm Label Group 1 |
Target Number of Participant 19 |
|
Arm Type Others |
|
Arm Description For period 1, each subject received Disgren capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. For period 2, each subject received Disgren enteric-coated capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. |
|
Arm 2 |
Arm Label Group 2 |
Target Number of Participant 19 |
|
Arm Type Others |
|
Arm Description For period 1, each subject received Disgren enteric-coated capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. For period 2, each subject received Disgren capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. |
9. Subject Eligibility
Condition(s)/Problem(s) | Not Applicable-Etc |
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Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 20Year~55Year |
|
Description •Healthy male subjects between the ages of 20 and 55 years at screening; •No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment; •Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis, etc.); •Hemorrhagic tendencies from medical history. |
|
Exclusion Criteria |
•Use of barbital drugs or alcohol abuse within 1 month prior to the study initiation; •Use of drugs disrupting this study within 10 days prior to the study initiation; •Medical history of clinically significant hypersensitivity to study drug; •Subject that is not eligible to participate at this study, based on discretion of study investigator; •Smoker; •Clinical abnormalities at clinical laboratory test. - The levels of aspartate aminotransferase (serum glutamic oxaloacetic transaminase) or alanine aminotransferase (serum glutamic pyruvic transaminase) > 1.25 x the upper limit of normal - The levels of Total bilirubin > 1.25 x the upper limit of normal - Platelet count(<180,000 or >350,000) - prothrombin time (PT), activated partial thromboplastin time (aPTT) , and bleeding time (BT) > normal |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | &Pharmacokinetics/dynamics | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | AUC(area under the concentration-time curve) |
|
Timepoint | pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 192.5, 193, 194, 196, 199, 202, 216 h |
|
Primary Outcome(s) 2 | ||
Outcome | Emax |
|
Timepoint | pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 196, 202, 216 h |
|
Secondary Outcome(s) 1 | ||
Outcome | Tmax(the time of Cmax) |
|
Timepoint | pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 192.5, 193, 194, 196, 199, 202, 216 h |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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