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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-027 | |||
| 2009_614 |
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This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Sitagliptin anhydrous formulation |
|
| 2 | Active Comparator | Sitagliptin monohydrate FMI formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate anhydrous formulation | Drug | Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication |
| Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate | Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods. |
| FG001 | 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous | 100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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 | Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Healthy Male and Female Subjects | Posted | Geometric Mean | Standard Deviation | μmol*hr/L | Through 72 Hours Following the Administration of the Medication |
|
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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 | 100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate | Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-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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| Comparator: sitagliptin phosphate monohydrate form | Drug | Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods. |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Full Range | Centimeters |
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| Weight | Mean | Full Range | Kilograms |
|
|
|
|
| Primary | Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Healthy Male and Female Subjects | Posted | Geometric Mean | Standard Deviation | μmol/L | Through 72 Hours Following the Administration of the Medication |
|
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous | 100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation) | 0 | 12 | 5 | 12 |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
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 |