Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0767-031 | |||
| 2009_606 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Fenofibrate U.S. Formulation |
|
| 2 | Active Comparator | Fenofibrate UK Formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate (U.S. formulation) | Drug | Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid | Predose and up to 168 hours postdose | |
| Maximum Plasma Concentration (Cmax) of Fenofibric Acid | Predose and up to 168 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 | TRICOR™ First, Then SUPRALIP™ | U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet |
| FG001 | SUPRALIP™ First, Then TRICOR™ | UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| 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)) of Fenofibric Acid | Healthy Male and Female subjects Aged 18 to 45 | Posted | Least Squares Mean | Standard Deviation | μg·hr/mL | Predose and up to 168 hours postdose |
|
Not provided
Not provided
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 | Tricor™ | U.S. formulation (TRICOR™) 160 mg tablet |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose Stools | Gastrointestinal disorders | MedDRA 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 |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fenofibrate (UK formulation) | Drug | Single dose of 160 mg fenofibrate UK formulation (Supralip®) 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 | Maximum Plasma Concentration (Cmax) of Fenofibric Acid | Healthy Male and Female subjects Aged 18 to 45 | Posted | Least Squares Mean | Standard Deviation | μg/mL | Predose and up to 168 hours postdose |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Supralip™ | UK formulation (SUPRALIP™) 160 mg tablet | 0 | 14 | 0 | 14 |
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.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |