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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0431A-080 | Other Identifier | Merck protocol number | |
| 2009_607 | Other Identifier | Merck registration number |
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This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sita + Met then Sita/Met FDC | Active Comparator | Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. |
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| Sita/Met FDC then Sita + Met | Active Comparator | Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate/metformin hydrochloride FDC | Drug | Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Serum samples were used to determine the AUC from time 0 to infinity for metformin. | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Metformin | Serum samples were used to determine the maximum concentration for metformin. | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sita + Met Then Sita/Met FDC | Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2. |
| FG001 | Sita/Met FDC Then Sita + Met | Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| 7-day Washout |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Serum samples were used to determine the AUC from time 0 to infinity for metformin. | All participants who completed and who had pharmacokinetic data available from at least one treatment period | Posted | Least Squares Mean | Standard Deviation | μg * hr/mL | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |
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Up to 24 days (including 14 days after administration of study drug in the last treatment period)
All participants as treated defined as all participants who received at least one dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sita + Met | Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitagliptin phosphate | Drug | Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods. |
|
| Metformin hydrochloride | Drug | Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | Mean | Full Range | Centimeters |
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| Weight | Mean | Full Range | Kilograms |
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| Secondary | Peak Plasma Concentration (Cmax) of Metformin | Serum samples were used to determine the maximum concentration for metformin. | All participants who completed and who had pharmacokinetic data available from at least one treatment period | Posted | Least Squares Mean | Standard Deviation | ng/mL | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |
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|
|
|
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Sita/Met FDC | Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose | 0 | 61 | 6 | 61 |
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |