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, s...
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| Veröffentlicht in: | Journal of clinical pharmacology 2001-02, Vol.41 (2), p.183-186 |
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| creator | McLean, Angus Browne, Susan Zhang, Yuxin Slaughter, Elizabeth Halstenson, Charles Couch, Richard |
| description | 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 × 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. |
| doi_str_mv | 10.1177/00912700122010005 |
| format | Article |
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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 × 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.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/00912700122010005</identifier><identifier>PMID: 11210399</identifier><identifier>CODEN: JCPCBR</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Anticonvulsants - administration & dosage ; Anticonvulsants - chemistry ; Anticonvulsants - pharmacokinetics ; Anticonvulsants. Antiepileptics. Antiparkinson agents ; Area Under Curve ; Biological and medical sciences ; Biological Availability ; Carbamazepine - administration & dosage ; Carbamazepine - chemistry ; Carbamazepine - pharmacokinetics ; Chemistry, Pharmaceutical ; Cross-Over Studies ; Delayed-Action Preparations ; Food ; Food-Drug Interactions ; Humans ; Male ; Medical sciences ; Middle Aged ; Neuropharmacology ; Pharmacology. 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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 × 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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anticonvulsants - administration & dosage</subject><subject>Anticonvulsants - chemistry</subject><subject>Anticonvulsants - pharmacokinetics</subject><subject>Anticonvulsants. Antiepileptics. Antiparkinson agents</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Biological Availability</subject><subject>Carbamazepine - administration & dosage</subject><subject>Carbamazepine - chemistry</subject><subject>Carbamazepine - pharmacokinetics</subject><subject>Chemistry, Pharmaceutical</subject><subject>Cross-Over Studies</subject><subject>Delayed-Action Preparations</subject><subject>Food</subject><subject>Food-Drug Interactions</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neuropharmacology</subject><subject>Pharmacology. 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Antiepileptics. Antiparkinson agents</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Biological Availability</topic><topic>Carbamazepine - administration & dosage</topic><topic>Carbamazepine - chemistry</topic><topic>Carbamazepine - pharmacokinetics</topic><topic>Chemistry, Pharmaceutical</topic><topic>Cross-Over Studies</topic><topic>Delayed-Action Preparations</topic><topic>Food</topic><topic>Food-Drug Interactions</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neuropharmacology</topic><topic>Pharmacology. 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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 × 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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>11210399</pmid><doi>10.1177/00912700122010005</doi><tpages>4</tpages></addata></record> |
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| ispartof | Journal of clinical pharmacology, 2001-02, Vol.41 (2), p.183-186 |
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| subjects | Adolescent Adult Anticonvulsants - administration & dosage Anticonvulsants - chemistry Anticonvulsants - pharmacokinetics Anticonvulsants. Antiepileptics. Antiparkinson agents Area Under Curve Biological and medical sciences Biological Availability Carbamazepine - administration & dosage Carbamazepine - chemistry Carbamazepine - pharmacokinetics Chemistry, Pharmaceutical Cross-Over Studies Delayed-Action Preparations Food Food-Drug Interactions Humans Male Medical sciences Middle Aged Neuropharmacology Pharmacology. Drug treatments |
| title | The Influence of Food on the Bioavailability of a Twice-Daily Controlled Release Carbamazepine Formulation |
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