Two open-label, randomized, crossover studies assessing the bioequivalence of ofloxacin administered as immediateand extended-release formulations in healthy subjects

Clinical Therapeutics

Volumn 28, Issue 12, 2006, Pages 2070-2080

  Marier, Jean Francois ^a   Ducharme, Murray P ^a   DiMarco, Marika ^a   Di Spirito, Mike ^a   Morelli, Gaetano ^a   Tippabhotla, Sudhakar K ^b   Badri, N ^b   Rampal, Ashok ^b   Monif, Tausif ^b  

^a MDS Inc   (Canada)

^b RANBAXY LABORATORIES LTD   (India)

Author keywords

extended release formulation; ofloxacin; pharmacokinetics; safety

Indexed keywords

DIMENHYDRINATE; OFLOXACIN; PARACETAMOL; UNCLASSIFIED DRUG; ZANOCIN;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADULT; AFRICAN AMERICAN; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BIOAVAILABILITY; BIOEQUIVALENCE; BLOATING; BLOOD SAMPLING; BODY WEIGHT; BURNING SENSATION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE SEQUENCE; DRUG FORMULATION; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; EUROPEAN AMERICAN; FEMALE; FLATULENCE; HEADACHE; HICCUP; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LOOSE FECES; MALE; METHODOLOGY; NAUSEA; NORMAL HUMAN; PALLOR; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STEADY STATE; STOMACH PAIN; UNPLEASANT SENSATION; VOMITING; WEAKNESS;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTI-BACTERIAL AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; OFLOXACIN; THERAPEUTIC EQUIVALENCY;

EID: 33846798133     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.12.018     Document Type: Article

References (16)

1. Pickerill K.E., Paladino J.A., and Schentag J.J. Comparison of the fluoroquinolones based on pharmacokinetic and pharmacodynamic parameters. Pharmacotherapy 20 (2000) 417-428
2. Scheld W.M. Maintaining fluoroquinolone class efficacy: Review of influencing factors. Emerg Infect Dis. 9 (2003) 1-9
3. Hooper D.C. Bacterial topoisomerases, anti-topoisomerases, and anti-topoisomerase resistance. Clin Infect Dis. 27 Suppl 1 (1998) S54-S63
4. Lamp K.C., Bailey E.M., and Rybak M.J. Ofloxacin clinical Pharmacokinetics. Clin Pharmacokinet 22 (1992) 32-46
5. O'Donnell J.A., and Gelone S.P. Fluoroquinolones. Infect Dis Clin North Am. 14 (2000) 489-513
6. Lode H., Hoffken G., Olschewski P., et al. Pharmacokinetics of ofloxacin after parenteral and oral administration. Antimicrob Agents Chemother 31 (1987) 1338-1342
7. Hyatt J.M., McKinnon P.S., Zimmer G.S., and Schentag J.J. The importance of pharmacokinetic/pharmacodynamic surrogate markers to outcome. Focus on antibacterial agents. Clin Pharmacokinet 28 (1995) 143-160
8. Wise R. Maximizing efficacy and reducing the emergence of resistance. J Antimicrob Chemother. 51 Suppl 1 (2003) 37-42
9. Wright D.H., Brown G.H., Peterson M.L., and Rotschafer J.C. Application of fluoroquinolone pharmacodynamics. J Antimicrob Chemother 46 (2000) 669-683
10. Metropolitan Life Insurance Company. New weight standards for men and women. Stat Bull Metropol Life Insur Co. 40 (1959) 1-4
11. MedDRA-the Medical Dictionary for Regulatory Activities (2006). http://www.meddramsso.com/MSSOWeb/index.htm
12. Zimmer D., Pickard V., Czembor W., and Muller C. Comparison of turbulentflow chromatography with auto mated solid-phase extraction in 96-well plates and liquid-liquid extraction used as plasma sample preparation techniques for liquid chromatography-tandem mass spectrometry. J Chromatogr A. 854 (1999) 23-35
13. Gibaldi M., and Perrier D. Noncompartmental analysis based on statistical moment theory. In: Swarbrick J. (Ed). Pharmacokinetics. 2nd ed. (1982), Marcel Dekker, New York, NY 409-417
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 15 (1987) 657-680
15. Hauschke D., Steinijans V.W., and Diletti E. A distribution-free procedure for the statistical analysis of bioequiva lence studies. Int J Clin Pharmacol Ther Toxicol. 28 (1990) 72-78
16. Chow S.C., and Liu J.P. Design and Analysis of Bioavailability and Bioequivalence Studies (1992), Marcel Dekker, New York, NY