Controlled, multidose, pharmacokinetic evaluation of two extended-release carbamazepine formulations (carbatrol and tegretol-XR)

Journal of Pharmaceutical Sciences

Volumn 87, Issue 12, 1998, Pages 1531-1534

  Stevens, Ruth E ^a  

^a Department of Pharmacokinetics and Scientific Affairs   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBAMAZEPINE;

ADULT; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG RELEASE; HEADACHE; HUMAN; HUMAN EXPERIMENT; NAUSEA; OSMOTIC PUMP; RANDOMIZED CONTROLLED TRIAL; RASH; SLOW RELEASE FORMULATION;

EID: 0031742446     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js980203+     Document Type: Article

References (16)

1. Lorge, M. Erfahrungen mit einem neuen antiepilelpticum, Tegretol (G 32.883), mit besonderer Wirkung auf die epileptische wesensveranderung. Schweiz Med Wochenschr. 1963, 63, 1042-1047.
2. Smith, D. B.; Mattson, R. H.; Cramer, J. A., et al. Results of a nationwide Veterans Administration Cooperative Study comparing the efficacy and toxicity of carbamazepine, phé nobarbital, phenytoin, and primidone. Epilepsia 1987, 28 Suppl 3, S50-S58.
3. Mattson, R. H.; Cramer, J. A.; Collins, J. F., et al. Comparison of carbamazepine, phénobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N. Engl. J. Med. 1985, 373, 145-151.
4. Mattson, R. H.; Cramer, J. A.; Collins, J. F. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. N. Engl. J. Med. 1992, 327, 765-771.
5. Prevey, M. L.: Delaney, R. C.; Cramer, J. A., et al. Effect of valproate on cognitive functioning. Comparison with carbamazepine. The Department of Veterans Affairs Epilepsy Cooperative Study 264 Group. Arch. Neural. 1996,53,10081016.
6. Geradin, A. P.; Abadie, F. V.; Campestrini, J. A.; Theobald, W. Pharmacokinetics of carbamazepine in normal humans after single and repeated oral doses. J. Pharmacokinet. Biopharm. 1976, 4, 521-535.
7. McKauge, L.; Tyrer, J. H.; Eadie, M. J. Factors influencing simultaneous concentrations of carbamazepine and its epoxide in plasma. Ther. Drug Monit. 1981, 3, 63-70.
8. Levy, R. H.; Wurden, C.J. Carbamazepine: Interactions with other drugs. In Antiepileptic drugs; Levy, R. H.; Mattson, R. H.; Meldrum, B. S.; Eds.; Raven: New York, 1995; pp 543554.
9. Morselli, P. L.; Gerna, M.; de Maio, D.; Zanda, G.; Viani, F.; Garattini, S. Pharmacokinetic studies on carbamazepine in volunteers and in epileptic patients. In Clinical pharmacology of anti-epileptic drugs; Schneider, H., et al., Eds.; Springer: Berlin; 1975; pp 87-96.
10. Cloyd, J. C.; Kriel, R. L.; Jones-Saete, C. M., et al. Comparison of sprinkle versus syrup formulations of valproate for bioavailability, tolerance, and preference. J. Pediatr. 1992, 120, 634-638.
11. Garnett, W. R.; Levy, B.; McLean, A. M., et al. A pharmacokinetic evaluation of twice-daily extended-release carbamazepine and four-times daily immediate-release carbamazepine in patients with epilepsy. Epilepsia 1998, 39, 274279.
12. The Tegretol OROS Osmotic Release Delivery System Study Group. Double-blind crossover comparison of Tegretol-XR and Tegretol in patients with epilepsy. Neurology 1995, 45, 1703-1707.
13. Thakker, K. M.; Mangat, S.; Garnett, W. R.; Levy, R. H.; Kochak, G. M. Comparative bioavailability and steady-state fluctuations of Tegretol commercial and carbamazepine OROS tablets in adult and pédiatrie epileptic patients. Biopharm. Drug Dispos. 1992, 13, 559-569.
14. Schuirmann, D. J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 1987, 15, 657-680.
15. Chen, M.-L.; Patnaik, R. Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design; The Division of Bioequivalence, Office of Generic Drugs, U.S. Food and Drug Administration: Rockville, MD, 1992.
16. Steinijans, V. W.; Hauck, W. W.; Diletti, E.; Hauschke, D.; Anderson, S. Effect of changing the bioequivalence range from (0.80,1.20) to (0.80,1.25) on the power and sample size. Int. J. Clin. Pharmacol. Ther. Toxicol. 1992, 30, 571-575.