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The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.
40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition Period 2: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition |
|
| Sequence B | Experimental | Period 1: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition Period 2: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIPS-2209-1 | Drug | QD, PO |
| |
| SIPS-2209-2, SIPS-2209-3 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of SIPS-2209-1 | AUCt: Area under the concentration-time curve from time zero to time | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| Cmax of SIPS-2209-1 | Cmax: Maximum plasma concentration of the drug | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of SIPS-2209-1 | AUCinf : AUC from time 0 to infinity | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| CL/F of SIPS-2209-1 | CL/F : Clearance |
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Inclusion Criteria:
Exclusion Criteria:
Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.
Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
Patients with the following diseases
Those who are deemed insufficient to participate in this clinical trial by investigators.
Woman who are pregnant or breastfeeding.
Those who have a history of clinically significant mental illness
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| Name | Affiliation | Role |
|---|---|---|
| Young Ee KWON, Ph.D | Samik Pharmaceutical Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samik Pharmaceutical Co. Ltd. | Incheon | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Drug |
QD, PO |
|
| predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| Tmax of SIPS-2209-1 | Tmax : Time to maximum plasma concentration of drug | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| t1/2 of SIPS-2209-1 | t1/2 : Terminal half-life | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |
| Vd/F of SIPS-2209-1 | Vd/F : Volume of distribution based on the terminal phase | predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours |