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Fenofibrate Bioequivalence Study (0767-031)

An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00928694
Enrollment
14
Registered
2009-06-26
Start date
2003-02-28
Completion date
2004-04-30
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

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.

Interventions

DRUGfenofibrate (U.S. formulation)

Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.

DRUGfenofibrate (UK formulation)

Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Subject is in good health * Subject is willing to follow all study guidelines

Exclusion criteria

* Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe * Female subject is receiving oral contraceptives or hormone replacement therapy

Design outcomes

Primary

MeasureTime frame
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric AcidPredose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric AcidPredose and up to 168 hours postdose

Participant flow

Participants by arm

ArmCount
All Participants14
Total14

Baseline characteristics

CharacteristicAll Participants
Age, Continuous36.7 years
Height169.64 Centimeters
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
9 Participants
Weight73.94 Kilograms

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 140 / 14
serious
Total, serious adverse events
0 / 140 / 14

Outcome results

Primary

Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid

Time frame: Predose and up to 168 hours postdose

Population: Healthy Male and Female subjects Aged 18 to 45

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
U.S. Formulation (TRICOR™)Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid116 μg·hr/mLStandard Deviation 35.1
UK Formulation (SUPRALIP™)Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid121 μg·hr/mLStandard Deviation 36.4
90% CI: [0.9, 1.02]
Primary

Maximum Plasma Concentration (Cmax) of Fenofibric Acid

Time frame: Predose and up to 168 hours postdose

Population: Healthy Male and Female subjects Aged 18 to 45

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
U.S. Formulation (TRICOR™)Maximum Plasma Concentration (Cmax) of Fenofibric Acid6.35 μg/mLStandard Deviation 1.61
UK Formulation (SUPRALIP™)Maximum Plasma Concentration (Cmax) of Fenofibric Acid6.48 μg/mLStandard Deviation 1.8
90% CI: [0.9, 1.06]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026