A Phase 1 interventional study of fenofibrate (U.S. formulation) and fenofibrate (UK formulation) in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 14 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fenofibrate U.S. Formulation
Drug: fenofibrate (U.S. formulation)
Fenofibrate UK Formulation
Drug: fenofibrate (UK formulation)
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
Also known as: Tricor®
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
Also known as: Supralip®
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
Time frame: Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
Time frame: Predose and up to 168 hours postdose
| Milestone | TRICOR™ First, Then SUPRALIP™ | SUPRALIP™ First, Then TRICOR™ |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | TRICOR™ First, Then SUPRALIP™ | SUPRALIP™ First, Then TRICOR™ |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| μg·hr/mL | U.S. Formulation (TRICOR™) | UK Formulation (SUPRALIP™) |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid | 116 ± 35.1 | 121 ± 36.4 |
| μg/mL | U.S. Formulation (TRICOR™) | UK Formulation (SUPRALIP™) |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Fenofibric Acid | 6.35 ± 1.61 | 6.48 ± 1.80 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tricor™ | — | 0/14 (0%) | 1/14 (7.1%) |
| Supralip™ | — | 0/14 (0%) | 0/14 (0%) |
| Event | Tricor™ | Supralip™ |
|---|---|---|
| Loose StoolsGastrointestinal disorders | 1/14 | 0/14 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 36.7 (23 to 45) |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 5 |
| Male | 9 |
| Height(Centimeters) | All Participants |
|---|---|
| Mean | 169.64 (154.94 to 187.96) |
| Weight(Kilograms) | All Participants |
|---|---|
| Mean | 73.94 (51.71 to 93.90) |
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC