Key result
Efavirenz capsule sprinkles mixed with food prove bioequivalent to intact fasting capsules in healthy adults.
Why the study?
The effect of mixing efavirenz capsule contents with a small amount of food on bioavailability and pharmacokinetics in healthy adults was evaluated.
Does mixing efavirenz capsule contents with a small amount of food affect its bioavailability compared to intact capsules under fasting conditions in healthy adults?
RCT (n=24)
Randomized, three-period, crossover
Does mixing efavirenz capsule contents with a small amount of food affect its bioavailability compared to intact capsules under fasting conditions in healthy adults?
Efavirenz capsule contents can be mixed with small amounts of food without altering its bioavailability, offering an alternative administration method.
Supports sprinkling efavirenz with food for patients unable to swallow capsules; confirms bioequivalence to intact capsules in an RCT.
PURPOSE: The effect of mixing the contents of efavirenz capsules (sprinkles) with a small amount of food on the bioavailability and pharmacokinetics of efavirenz in healthy adults was evaluated. METHODS: In a randomized, three-period, crossover study, 24 healthy adult subjects were divided equally into two groups. Group I received treatments A, B, and C, and those in group II received treatments A, D, and E. Treatment A was three efavirenz 200-mg intact capsules under fasting conditions. Treatments B, C, D, and E were three efavirenz 200-mg capsule contents mixed with two teaspoons of applesauce, grape jelly, yogurt, or infant formula, respectively. A single dose was given on days 1, 21, and 41. The steady-state mean maximum observed concentration, time of maximum observed concentration, area under the concentration-time curve (AUC) half-life, taste, and safety were assessed. RESULTS: The AUC after administration of a single 600-mg dose of efavirenz sprinkles mixed with two teaspoons of any of the food vehicles to healthy adults was bioequivalent to a 600-mg efavirenz dose given as intact capsules under fasting conditions. Subjects rated efavirenz mixed with grape jelly as the most palatable. Adverse events and laboratory abnormalities were similar for all treatments. CONCLUSION: The AUC of efavirenz 600 mg administered as capsule sprinkles with two teaspoons of applesauce, grape jelly, yogurt, or infant formula was bioequivalent to a single dose of efavirenz 600 mg given as intact capsules under fasting conditions in healthy adults.
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Kaul et al. (2010) conducted an RCT in Healthy adults (n=24). Efavirenz capsule contents mixed with food vs. Efavirenz 600 mg intact capsules under fasting conditions was evaluated on Area under the concentration-time curve (AUC). A single 600-mg dose of efavirenz capsule sprinkles mixed with food was bioequivalent to intact capsules given under fasting conditions in healthy adults.
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