The influence of food on the bioavailability of a twice-daily controlled release carbamazepine formulation.
Carbatrol, a new dosage form of carbamazepine (CBZ), was developed consisting of three different types of pellets (immediate release, controlled release, and enteric release). The objective of this study was to explore the influence of food on absorption of CBZ. This was a randomized, open-label, single-dose crossover study conducted in 12 healthy volunteers. Treatments were 2 x 200 mg Carbatrol with a high-fat meal, fasted, or sprinkled over applesauce (but otherwise fasted). Each subject received one dose of each treatment separated by a washout period of at least 2 weeks. CBZ bioequivalence was established based on the equivalence of AUC (extent of absorption) in all three conditions. Carbatrol may be taken with or without food or the capsule opened and sprinkled on food.
McLean
A
A
Shire Laboratories, Inc., 1550 East Gude Drive, Rockville, MD 20850, USA.
Browne
S
S
Zhang
Y
Y
Slaughter
E
E
Halstenson
C
C
Couch
R
R
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D019540:Area Under Curve; D001682:Biological Availability; D002220:Carbamazepine / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005502:Food; D018565:Food-Drug Interactions; D006801:Humans; D008297:Male; D008875:Middle Aged
D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D002220:Carbamazepine