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This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Experimental |
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| Treatment period 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide | Drug | Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration | ||
| Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet | ||
| Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration | ||
| NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Repaglinide AUC after NN4440 (1/500) during fed state | ||
| Repaglinide Cmax after NN4440 ((1/500) during fed state | ||
| Change in physical examinations from screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18666804 | Result | Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C072379 | repaglinide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| metformin | Drug | Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods |
|
| repaglinide and metformin combination tablet | Drug | Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods |
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| Vital signs |