Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican population

Biopharmaceutics and Drug Disposition

Volumn 25, Issue 5, 2004, Pages 203-209

  Marcelin Jimenez G ^a   Hernández, José ^a   Ángeles, Alionka P ^a   Contreras, L ^a   Hinojosa, M ^a   Rivera, L ^a   Martinez Rossier L ^a   Amancio, O ^a   Fernandez A ^a  

^a HOSPITAL GENERAL DE MÉXICO   (Mexico)

Author keywords

Bioequivalence; HPLC; Ketoconazole; Pharmacokinetics

Indexed keywords

ASTEMIZOLE; CHLORPHENIRAMINE; CITRATE SODIUM; HEPARIN; KETOCONAZOLE; ONOFIN K; PARACETAMOL;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG FORMULATION; DRUG HALF LIFE; FEMALE; FOOD DRUG INTERACTION; GASTROINTESTINAL SYMPTOM; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MEXICO; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; TABLET; ULTRAVIOLET RADIATION;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; CHEMISTRY, PHARMACEUTICAL; CONFIDENCE INTERVALS; CROSS-OVER STUDIES; FEMALE; HUMANS; KETOCONAZOLE; MEXICO; MIDDLE AGED; TABLETS, ENTERIC-COATED; THERAPEUTIC EQUIVALENCY;

EID: 4043140104     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.399     Document Type: Article

References (16)

1. Vanden Bosche H, Koymans HL, Moereels H. P450 inhibitors of use in medical treatment: focus on mechanism of action. Pharm Ther 1995; 67: 1-22.
2. Daneshmend TK, Warnock DW. Clinical pharmacokinetics of ketoconazole. Clin Pharmacokinet 1988; 14: 13-34.
3. Albougy HA, Naidoo S. A systemic review of the management of oral candidiasis associated with HIV/AIDS. SADJ 2002; 11: 457-466.
4. Dabbs ER, Naidoo S, Lephoto C, Nikitina N. Pathogenic Nocardia, Rhodococcus and related, organisms are highly susceptible to imidazole antifungals. Antimicrob Agents Chemother 2003; 47: 1476-1478.
5. Peehl DM, Seto E, Hsu JY, Feldman D. Preclinical activity of ketoconazole in combination with calcitriol or the vitamin D analogue EB1089 in prostate cancer cells. J Urol 2002; 168: 1583-1588.
6. Tzanakakis GN, Krambovitis E, Tsatsakis AM, Vezeridis MP. The preventive effect of ketoconazole on experimental metastases from a human pancreatic carcinoma may be related to its effect on prostaglandin synthesis. Int J Gastrointest Cancer 2002; 32: 23-30.
7. Johnson BM, Chen W, Borchardt RT, Charman WN, Porter CJ. A kinetic evaluation of the absorption, efflux and metabolism of verapamil in the autoperfusated rat jejunum. J Pharmacol Exp Ther 2003; 1305: 151-158.
8. Woo JS, Lee CH, SMI CK, Hwany SJ. Enhanced oral bioavailability of paclitaxel by the co-administration of the P-glycoprotein inhibitor KR30031. Pharm Res 2003; 20: 24-30.
9. Badcock NR, Bartholomeuz FD, Frewin DB, Sansom LN, Reid JG. The pharmacokinetics of ketoconazole after chronic administration in adults. Eur J Clin Pharm 1987; 33: 531-534.
10. Baxter JS, Brass C, Schentag JJ, Slaughter RL. Pharmacokinetics of ketoconazole administered intravenously to dogs and orally as tablet and solution to humans and dogs. J Pharm Sci 1986; 75: 443-447.
11. Yuen KH, Peh KK. Simple high performance liquid chromatographic method for determination of ketoconazole inhuman plasma. J Chromatogr B 1998; 715: 436-440.
12. NOM-177-SSA1-1998. Pruebas y Procedimientos para Demostrar Intercambiabilidad de Formulaciones Farmacéuticas. Secretaría de Salud: México.
13. WINNONLIN version 3.1 software. Pharshigt Corporation CA, USA, 2000.
14. FDA. Guidance For Industry. Statistical Approaches to Establishing Bioequivalence. US Department of Health and Human Services. FDA (CDER), January 2001.
15. SAS/STAT module version 8.2 software. The SAS Institute, Inc: NC, USA, 1999.
16. Badcock NR. Micro-determination of ketoconazole in plasma or serum by high performance liquid chromatography. J Chromatogr Biomed Appl 1984; 306: 436-440.