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This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of CT-L03 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (L03RD1/L03RD2 -> CT-L03) | Experimental | Administration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of CT-L03 |
|
| B (CT-L03 -> L03RD1/L03RD2) | Experimental | Administration of 1 table of CT-L03, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L03RD1 | Drug | 1 tablet of L03RD1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours | |
| Cmax | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | Area under the plasma concentration-time curve from time 0 to infinity | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
| AUCt/AUCinf | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
1) Subject who have taken a drug that induces or inhibits drug metabolizing enzymes (e.g. barbiturates) within 1 month before the start of the study(date of first administration), or if taken a drug that may affect this study within 10 days before the start of the study(date of first administration).
2) Participated in another clinical trial or bioequivalence study and received an investigational product within 6 months of first dose of investigational product.
3) Donated whole blood within 8 weeks, blood components within 2 weeks, or received a transfusion within 4 weeks of first dose of investigational product.
4) Subject with a history of gastrointestinal resection that may affect drug absorption (excluding appendectomy and hernia surgery).
5) Subjects who meet any of the following criteria within 1 month prior to the first dose
6) Subjects with any of the following medical conditions
7) Subject with a history of clinically significant mental illness.
8) Subject who is judged by the principal investigator(or the delegated investigator) to be unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria.
9) For female subjects, those who are suspected of being pregnant or breastfeeding.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H plus Yangji Hostpital | Seoul | 08756 | South Korea |
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| L03RD2 |
| Drug |
2 tablets of L03RD2 |
|
| CT-L03 | Drug | 1 tablet of CT-L03 |
|
| Tmax | Time of peak plasma concentration | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
| t1/2 | Half-life | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
| CL/F | Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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