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Systemic exposure to rosiglitazone is unaltered by food
M I Freed1, A Allen, D K Jorkasky
1SmithKline Beecham Clinical Pharmacology Unit, Presbyterian Medical Center of the University of Pennsylvania Health System, Philadelphia 19104, USA. Martin_I_Freed@sbphrd.com
European Journal of Clinical Pharmacology
|April 17, 1999
Summary
Food does not significantly impact overall exposure to rosiglitazone, an insulin sensitizer. This finding supports taking rosiglitazone with or without meals for type 2 diabetes management.
Area of Science:
- Pharmacology
- Endocrinology
- Clinical Therapeutics
Background:
- Rosiglitazone is an insulin sensitizer used for type 2 diabetes mellitus.
- Understanding food effects on drug pharmacokinetics is crucial for optimizing dosing regimens.
Purpose of the Study:
- To investigate the impact of food intake on the bioavailability and pharmacokinetics of rosiglitazone.
Main Methods:
- A randomized, open-label, crossover study involving 12 healthy males.
- Rosiglitazone 2 mg was administered in fasting and fed (high-fat breakfast) states.
- Primary endpoints included AUC(0-inf) and Cmax.
Main Results:
- Rosiglitazone was safe and well-tolerated in single oral doses.
- Food did not affect overall rosiglitazone exposure (AUC(0-inf)).
- Maximum concentration (Cmax) was reduced by ~20% and Tmax was delayed when taken with food, indicating more gradual absorption.
Conclusions:
- Food does not alter the overall bioavailability of rosiglitazone.
- These findings support administering rosiglitazone without regard to meals for type 2 diabetes treatment.