Bioequivalence of two oral extended release formulations of ciprofloxacin tablets in healthymale volunteers under fed and fasting conditions

Journal of Bioequivalence and Bioavailability

Volumn 3, Issue 2, 2011, Pages 038-042

  Omari, Derar M ^a   Johary, Dalia ^a   Salem, Isam I ^a   Najib, Naji ^a   Sallam, Assayed A ^a  

^a AL ZAYTOONAH UNIVERSITY OF JORDAN   (Jordan)

Author keywords

Bioavailability; Bioequivalence; Ciprofloxacin; Extended release; Pharmacokinetics

Indexed keywords

CIPROFLOXACIN;

ACCURACY; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSAGE FORM COMPARISON; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY AND SPECIFICITY; SINGLE DRUG DOSE; TABLET FORMULATION; TEST MEAL; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION PROCESS;

EID: 79958714080     PISSN: None     EISSN: 09750851     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. Aballah RM, Alam SM, Awaad FM, Dham R, El-Kersh A, et al. (2002) Bioequivalence of two brands of ciprofloxacin 750mg tablets (Sarf and Ciprobay) in healthy human volunteers. Drug Dev Ind Pharm 28: 423-439.
2. Azad MA, A Shikullah, Latif AHM, Abul Hasnat (2007) Bioequivalence and pharmacokinetic study of two formulations ciprofloxacin tablets in healthy male volunteers. J App Res 7: 150-157.
3. Bauernfeind A, Petermüller C (1983) In vitro activity of ciprofloxacin, norfloxacin and nalidixic acid. Eur J Clin Microbiol 2: 111-115.
4. Borner K, Lode H, Elvers A (1982) Determination of apalcillin and its metabolites in human body fluids by high-pressure liquid chromatography. Antimicrob Agents Chemother 22: 949-953.
5. Chin NX, Neu HC (1984) Ciprofloxacin, a quinolone carboxylic acid compound active against aerobic and anaerobic bacteria. Antimicrob Agents Chemother 25: 319-326.
6. CIPRO® XR, PDR 2007
7. Fass R (1987) Efficacy and safety of oral ciprofloxacin for treatment of serious urinary tract infections. Antimicrob agents chemother 31: 148-150.
8. Fourcroy JL, Berner B, Chiang Y, Cramer M, Rowe L, et al. (2005) Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women. Antimicrob agents chemother 49: 4137-4143.
9. Rockville MD (2002) Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations.
10. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/CM126833.pdfhttp://www.fda.gov/cder/guidance/index.htm
11. Goodman LJ, Fliegelman RM, Trenholme GM, Kaplan RL (1984) Comparative in vitro activity of ciprofloxacin against Campylobacter spp. and other bacterial enteric pathogens. Antimicrob Agents Chemother 25: 504-506.
12. Hickerson AD, Carson CC (2006) The treatment of urinary tract infections and use of ciprofloxacin extended release. Expert Opin Investig Drugs 15: 519-32.
13. Malinowski H, Johnson S (2005) Bioavailability and Bioequivalence Testing, in Remington's The Sciences and practice of pharmacy, 21st edn, Lipincott Williams &Wilkins, pp 1037-1046.
14. Meagher AK, Forrest A, Dalhoff A, Stass H, Schentagl JJ (2004) Novel Pharmacokinetic-Pharmacodynamic model for prediction of outcomes with an extended-release formulation of ciprofloxacin. Antimicrob agents chemother. 48: 2061-2068.
15. Mirone V, Fusco F, Taglialatela D, Verze P, Di Vito C, et al. (2009) Efficacy and safety of ciprofloxacin XR 1000 mg once daily versus ciprofloxacin 500 mg twice daily in the treatment of complicated urinary tract infections. J Chemother 21: 651-660.
16. Steinijans V, Diletti E (1983) Statistical analysis of bioavailability studies: Parametric and nonparametric confidence intervals. Eur J Clin Pharmacol 24: 127-136.
17. Talan DA, Naber KG, Palou J, Elkharrat D (2004) Extended-release ciprofloxacin (Cipro XR) for treatment of urinary tract infections. Int J Antimicrob Agents 1: S54-66.
18. Wagenlehner FM, Kinzig-Schippers M, Tischmeyer U, Wagenlehner C, Sörgel F, et al. (2006) Urinary Bactericidal Activity of Extended-Release Ciprofloxacin (1,000 Milligrams) versus Levofloxacin (500 Milligrams) in Healthy Volunteers Receiving a Single Oral Dose. Antimicrob agents chemother 50: 3947-3949.
19. Waugh J, Keating GM (2004) Ciprofloxacin extended release: in the treatment of urinary tract infections and uncomplicated pyelonephritis. Drugs Aging 21: 55-64.