TriCor
Abbott Laboratories
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Improved Formulation

Simplified, convenient dosing helps patients reach their lipid goals

Proven equivalent bioavailability with or without food (1)

NanoCrystal® Technology-145 mg fed vs fasting*
NanoCrystal® Technology-145 mg fed vs fasting
Mean plasma concentration of fenofibric acid after a single administration of one 145-mg fenofibrate tablet in low-fat fed and fasting conditions (n=44) in healthy subjects

*The two regimens high-fat fed and fasting were found to be bioequivalent, as were the two regimens low-fat fed and fasting (1)

One of the meals required for food-effect bioavailability studies should be a high-fat, high-calorie test meal (2)

Bioavailability: AUC+Cmax


Previous Micronized Formulation-160 mg fed vs fasting
Previous Micronized Formulation-160 mg fed vs fasting
Mean plasma concentration of fenofibric acid after administration of one 160-mg fenofibrate tablet in low-fat fed (n=36) and fasting (n=36) conditions in healthy subjects

Absorption: AUC

In a nationwide survey of 385 patients receiving the previous formulation of TriCor (1):

1 out of 3 patients responded that they took TriCor without a meal 1 out of 3 patients responded that they took TriCor without a meal
66% of TriCor patients surveyed prefer taking medication without regard to meals 66% of TriCor patients surveyed prefer taking medication without regard to meals

TriCor 145 is widely available (1)

  • 90% managed health care coverage nationwide
  • 99% stocking for immediate availability

Patients qualified for this market research were current users of TriCor, taking the medication for at least two months between October and December 2003. Sample provided via nationwide pharmacy network of approximately 1500 independent, chain and mass merchandise pharmacies. Patients were recruited in blinded fashion to participate in a general healthcare survey. Survey data weighted to reflect national distribution of TriCor patients by geography, gender and age. Margin of error = ±5 percentage points at the 95% confidence level

35% without a meal

References

  1. Data on file, Abbott Laboratories.
  2. Food and Drug Administration. Guidance for industry food-effect bioavailability and fed bioequivalence studies. Available at: www.fda.gov/cder/guidance/index.htm. Accessed July 1, 2004.
06H-030-Q590-4