Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0663-070 | |||
| 2009_623 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Etoricoxib, 20% tablet |
|
| B | Active Comparator | Etoricoxib, 30% tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoricoxib | Drug | Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib | The area under the plasma concentration vs time curve. | Through 120 Hours Postdose |
| Peak Plasma Concentration (Cmax) for Etoricoxib | Through 120 Hours Postdose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etoricoxib FMI Then Etoricoxib URC | FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction |
| FG001 | Etoricoxib URC Then Etoricoxib FMI | URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants in Study |
| 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 Etoricoxib | The area under the plasma concentration vs time curve. | All healthy adult subjects completed the study and were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | µg times hr/mL | Through 120 Hours Postdose |
|
Not provided
Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etoricoxib FMI | FMI Formulation (20%), Final Market Image |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: etoricoxib | Drug | Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods. |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Full Range | Centimeters |
|
| Weight | Mean | Full Range | Kilograms |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Peak Plasma Concentration (Cmax) for Etoricoxib | All healthy adult subjects completed the study and were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | ng/mL | Through 120 Hours Postdose |
|
|
|
|
| 0 |
| 36 |
| 9 |
| 36 |
| EG001 | Etoricoxib URC | URC Formulation (30%), Unmilled Roller Compaction | 0 | 36 | 12 | 36 |
| Loose Stools | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | 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.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |