A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers

Therapeutic Advances in Chronic Disease

Volumn 1, Issue 4, 2010, Pages 141-148

  Quinones, Luis ^a   Sasso, Jaime ^a   Tamayo, Evelyn ^a   Catalan, Johanna ^a   Gonzalez, Juan Paplo ^a   Escala, Mario ^a   Varela, Nelson ^a   León, Jorge ^a   Caceres, Dante Daniel ^a   Saavedra, Ivan ^a  

^a UNIVERSITY OF CHILE   (Chile)

Author keywords

bioavailability; bioequivalence; gabapentin; pharmacokinetics; pregabalin

Indexed keywords

PREGABALIN; PREGOBIN; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHILE; COMPARATIVE STUDY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PARAMETRIC TEST; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOMNOLENCE; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; XEROSTOMIA;

EID: 79953013963     PISSN: 20406223     EISSN: None     Source Type: Journal    
DOI: 10.1177/2040622310379932     Document Type: Article

References (20)

1. Blommel, M.L. and Blommel, A.L. ( 2007) Pregabalin: an antiepileptic agent useful for neuropathic pain. Am J Health Syst Pharm 64: 1475-1482.
2. Bockbrader, H.N., Radulovic, L.L., Posvar, E.L., Strand, J.C., Alvey, C.W., Busch, J.A. et al. (2010) Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol 50 (8): 941-950.
3. Busch, J.A., Strand, J.A. and Posvar, E.L. ( 1998) Pregabalin (CI-1008) single-dose pharmacokinetics and safety / tolerance in healthy subjects after oral administration of pregabalin solution or capsule doses. Epilepsia 39(Suppl 6): 58.
4. Chow, S. Ch. and Wang, H. ( 2001) On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodynam 28: 155-169.
5. Crofford, L.J., Rowbotham, M.C., Mease, P.J., Russell, I.J., Dworkin, R.H., Corbin, A.E. et al. (2005) Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 52: 1264-1273.
6. Dooley, D.J., Donovan, C.M. and Pugsley, T.A. ( 2000a) Stimulus-dependent modulation of [ (3)H]norepinephrine release from rat neocortical slices by gabapentin and pregabalin. J Pharmacol Exp Ther 295: 1086-1093.
7. Dooley, D.J., Mieske, C.A. and Borosky, S.A. ( 2000b) Inhibition of K(+)-evoked glutamate release from rat neocortical and hippocampal slices by gabapentin. Neurosci Lett 280: 107-110.
8. Food and Drug Administration (2003) BA and BE Studies for Orally Administered Drug Products-General Considerations. FDA Center for Drug Evaluation and Research.
9. Fink, K., Dooley, D.J., Meder, W.P., Suman-Chauhan, N., Duffy, S., Clusmann, H. et al. (2002) Inhibition of neuronal Ca(2+) influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology 42: 229-236.
10. Ji, H.Y., Jeong, D.W., Kim, Y.H., Kim, H.H., Yoon, Y.S., Lee, K.C. et al. (2006) Determination of gabapentin in human plasma using hydrophilic interaction liquid chromatography with tandem mass spectrometry. Rapid Comm Mass Spectro 20: 2127-2132.
11. Kwan, P. ( 2006) Pregabalin: a new drug for epilepsy, neuropathic pain and anxiety. Hong Kong Med Diary 11: 15-16.
12. Nuremberg Doctors’ Trial (1964) Declaration of Helsinki 7 December. BMJ 313: 1448-1449.
13. Ritschel, W.A. ( 1986) AUC-RPP: BASIC computer program for compartment model independent pharmacokinetic analysis. Methods Find Exp Clin Pharmacol 8: 633-640.
14. Rogawski, M.A. and Taylor, C.P. ( 2006) Calcium channel α2-δ subunit: a new antiepileptic drug target. Epilepsy Res 69: 183-272.
15. Schuirmann, D.J. ( 1987) A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15: 657-680.
16. Shneker, B.F. and McAuley, J.W. ( 2005) Pregabalin: a new neuromodulator with broad therapeutic indications. Ann Pharmacother 39: 2029-2037.
17. Siddall, P.J., Cousins, M.J., Otte, A., Griesing, T., Chambers, R. and Murphy, T.K. ( 2006) Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology 67: 1792-1800.
18. Stewart, B.H., Kugler, A.R., Thompson, P.R. and Bockbrader, H.N. ( 1993) A saturable transport mechanism in the intestinal absorption of gabapentin is the underlying cause of the lack of proportionality between increasing dose and drug levels in plasma. Pharm Res 10: 276-281.
19. World Health Organization (1998) Guidelines on registration requirements to establish interchangeability. In Code of Federal Regulations. Title 21, part 320. “Bioavailability and Bioequivalence Requirements”. Technical Report Series N (WHO-96). Washington, DC: WHO.
20. Zareba, G. ( 2005) Pregabalin: a new agent for the treatment of neuropathic pain. Drugs Today (Barc) 41: 509-516.