Clarithromycin bioequivalence study of two oral formulations in healthy human volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 38, Issue 7, 2000, Pages 345-354

  Lerner, F E ^a   Caliendo, G ^b   Santagada, V ^b   Santana, G S M ^c   Moraes, M E A ^c   De Nucci, G ^d  

^a UNIVERSITY OF CAMPINAS   (Brazil)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c FEDERAL UNIVERSITY OF CEARÁ   (Brazil)

^d NONE   (Brazil)

Author keywords

Bioavailability; Human; Hydroxyclarithromycin; Mass spectrometry; Pharmacokinetic

Indexed keywords

14 HYDROXYCLARITHROMYCIN; CLARITHROMYCIN; DRUG METABOLITE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG METABOLISM; FEMALE; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; TABLET;

EID: 0033947466     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP38345     Document Type: Article

References (28)

1. Borner K, Hartwig H, Lode H 1992 Determination of clarithromycin and its R-14-hydroxymetabolite in human serum and urine by reversed-phase HPLC and electrochemical detection. Fresenius J Anal Chem 343: 109-110
2. Chen ML, Jackson AJ 1995 The role of the metabolites in bioequivalence assessment. II. Drugs with linear pharmacokinetics and first pass effect. Pharm Res 12: 700-708
3. Chu SY, Senello LT, Bunnel ST, Varga LL, Wilson DS, Sonders RS 1992 Pharmacokinetics of clarithromycin, a new macrolide, after single ascending doses. Antimicrob Agents Chemother 36: 2447-2453
4. Chu S-Y, Sennello LT, Sonders RC 1991 Simultaneous determination of clarithromycin and 14-(R)-hydroxyclarithromycin in plasma and urine using high-performance liquid chromatography with electrochemical detection. J Chromatogr 571: 199-208
5. Dallal GE, Wilkinson L 1986 An analytic approximation to the distribution of Lilliefors' test statistic for normality. Am Statistician 40: 294-296
6. Davey PG 1991 The pharmacokinetics of clarithromycin and its 14-OH metabolite. J Hosp Inf 19 (Suppl A): 29-37
7. Duth GS 1984 Assay of erythromycin from human serum by high-performance liquid chromatography with electrochemical detection. J Liquid Chromatogr 7: 1023-1032
8. Ferrero JL, Bopp BA, Marsh KC, Quigley SC, Johnson MJ, Anderson DJ, Lamm JE, Tolman KC, Sanders SW, Cavanaugh JH et al 1990 Metabolism and disposition of clarithromycin in man. Drug Metab Dispos 18: 441-446
9. Food and Drug Administration 1985 Bioavailability and Bioequivalence Requirements. Fed Register 320: 154-173
10. Food and Drug Administration 1993 In vivo bioequivalence guidances. Pharmacopeia Forum 19: 6501-6508
11. Fraschini F, Scaglione F, Dermatini G 1993 Clarithromycin clinical pharmacokinetics. Clin Pharmacokinet 25: 189-204
12. Fraschini F, Scaglione F, Pintucci G, Maccarinelli G, Duganani S, Demartini G 1991 The diffusion of clarithromycin and roxithromycin into nasal mucosa, tonsil and lung in humans. J Antimicrob Chemother 27 (Suppl 4): 61-65
13. Hardy DJ, Swanson RN, Rode RA, Marsh K, Shipkowitz NL, Clement JJ 1990 Enhancement of the in vitro and in vivo activities of clarithromycin against Haemophilus influenzae by 14-hydroxy-clarithromycin, its major metabolite in humans. Antimicrob Agents Chemother 34: 1407-1413
14. Hedenmo M, Eriksson BM 1995 Liquid chromatographic determination of the macrolide antibiotics roxithromycin and clarithromycin in plasma by automated solid-phase extraction and electrochemical detection. J Chromatogr A 692: 161-166
15. Igea JM, Lazaro M 1998 Hypersensitivity reaction to clarithromycin. Allergy 53: 107-109
16. Jorgensen JH, Maher LA, Howell AW 1991 Activity of clarithromycin and its principal human metabolite against Haemophilus influenzae. Antimicrob Agents Chemother 35: 1524-1526
17. Kirst HA, Sides GD 1989 New directions for macrolide antibiotics: structural modifications and in vitro activity. Antimicrob Agents Chemother 33: 1413-1418
18. Lode H, Boeckh M, Schaber T 1993 Human Pharmacokinetics of macrolide antibiotics. In: Arnette A (ed) Macrolides: Chemistry, Pharmacology and Clinical Uses. Blackwell, Oxford, pp 409-421
19. Moraes LA, Lerner FE, Moraes MEA, Moraes MO, Corso G, De Nucci G 1999 Fluconazole bioequivalence study: quantification by tandem mass spectrometry. Ther Drug Monit 21: 200-207
20. Moraes MEA, Lerner FE, Perozin M, Moraes MO, Frota Bezerra FA, Sucupira M, Corso G, De Nucci G 1998 Comparative bioavailability of two sertraline tablet formulations in healthy human volunteers after a single dose administration. Int J Clin Pharmacol Ther 12: 661-665
21. Moraes MO, Lerner FE, Corso G, Frota Bezerra FA, Moraes MEA, De Nucci G 1999 Fluoxetine Bioequivalence Study: Quantification of fluoxetine and norfluoxetine by liquid chromatography coupled to mass spectrometry (LC-MS). J Clin Pharmacol 39: 1-9
22. Morimoto S, Takahashi Y, Watanabe Y, Omura S 1984 Chemical modification of erythromycins. I. Synthesis and antibacterial activity of 6-o-methylerythromycins. Am J Antibiot 37: 187-189
23. Pan HY 1990 Comparative pharmacokinetics and pharmacodynamics of pravastatine and lovastatine. J Clin Pharmacol 30: 1128-1135
24. Pentikainen PJ 1992 Comparative pharmacokinetics of lovastatin, simvastatin and pravastatine in human. J Clin Pharmacol 32: 136-140
25. Peters DH, Clissold SP 1992 Clarithromycin: a review of its antimicrobial activity, pharmacokinetic properties and therapeutical potential. Drugs 44: 117-164
26. Salmonson T 1996 Current practice of BA/BE requirements for immediate release products in EU. Abstract from Bio International: Bioavailability, Bioequivalence and Pharmacokinetics, International Conference of F.I.P. Bio-International, Tokyo, Japan, pp 16-19
27. Sturgill MG, Rapp RP 1992 Clarithromycin: review of a new macrolide antibiotic with improved microbiologic spectrum and favorable pharmacokinetic and adverse effect profiles. Ann Pharmacother 26: 1099-1108
28. Tucker GT, Rostami A, Jackson 1993 Metabolites measurements in bioequivalence studies: theoretical considerations. In: Midha KK, Blume HH (eds) Bio-International. Bioavailability, Bioequivalence and Pharmacokinetics. Medpharma Scientific Publications, Stuttgart, pp 163-170