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Volumn 32, Issue 10, 2010, Pages 1822-1831

A bioequivalence comparison of two formulations of rifampicin (300- vs 150-mg capsules): An open-label, randomized, two-treatment, two-way crossover study in healthy volunteers

Author keywords

Bioequivalence; HPLC; Pharmacokinetics; Rifampicin; Tuberculosis

Indexed keywords

25 DESACETYL RIFAMPICIN; DRUG METABOLITE; RIFAMPICIN; UNCLASSIFIED DRUG;

EID: 78650598044     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.09.006     Document Type: Article
Times cited : (8)

References (20)
  • 1
    • 0038178785 scopus 로고    scopus 로고
    • Antimicrobial agents: Drugs used in the chemotherapy of tuberculosis, Mycobacterium avium complex disease and leprosy
    • McGraw-Hill, New York, NY, J.G. Hardman, L.E. Limbird, A. Goodman Gilman (Eds.)
    • Petri WA Antimicrobial agents: Drugs used in the chemotherapy of tuberculosis, Mycobacterium avium complex disease and leprosy. Goodman & Oilman's the Pharmacological Basis ofTherapeutics 2001, 1273-1294. McGraw-Hill, New York, NY. 10th ed. J.G. Hardman, L.E. Limbird, A. Goodman Gilman (Eds.).
    • (2001) Goodman & Oilman's the Pharmacological Basis ofTherapeutics , pp. 1273-1294
    • Petri, W.A.1
  • 2
    • 0037202688 scopus 로고    scopus 로고
    • Current medical treatment for tuberculosis
    • Chan ED, Iseman MD Current medical treatment for tuberculosis. BMJ. 2002, 325:1282-1286.
    • (2002) BMJ. , vol.325 , pp. 1282-1286
    • Chan, E.D.1    Iseman, M.D.2
  • 3
    • 0032929038 scopus 로고    scopus 로고
    • Pharmacokinetics of rifampin under fasting conditions, with food, and with antacids [published correction appears in Chest. 1999;115:1485]
    • Peloquin CA, Namdar R, Singleton MD, Nix DE Pharmacokinetics of rifampin under fasting conditions, with food, and with antacids [published correction appears in Chest. 1999;115:1485]. Chest. 1999, 115:12-18.
    • (1999) Chest. , vol.115 , pp. 12-18
    • Peloquin, C.A.1    Namdar, R.2    Singleton, M.D.3    Nix, D.E.4
  • 4
    • 84855619681 scopus 로고    scopus 로고
    • Rxlist.com.rifampin-clinical pharmacology, Accessed August 23, 2010.
    • Rxlist.com.rifampin-clinical pharmacology, Accessed August 23, 2010. http://www.rxlist.com/rifadin-drug.htm.
  • 5
    • 0017944237 scopus 로고
    • Clinical pharmacokinetics of rifampicin
    • Acocella G Clinical pharmacokinetics of rifampicin. Clin Pharmacokinet. 1978, 3:108-127.
    • (1978) Clin Pharmacokinet. , vol.3 , pp. 108-127
    • Acocella, G.1
  • 7
    • 0003455042 scopus 로고    scopus 로고
    • US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Accessed August 23, 2010.
    • Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations 2003, US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Accessed August 23, 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
    • (2003) Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations
  • 8
    • 0003478656 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Proprietary Medicinal Products (CPMP)Committee for Proprietary Medicinal Products (CPMP), Accessed August 23, 2010.
    • Note for guidance on the investigation of bioavailability and bioequivalence The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Proprietary Medicinal Products (CPMP)Committee for Proprietary Medicinal Products (CPMP), Accessed August 23, 2010. http://apps.who.int/prequal/info_applicants/BE/emea_bioequiv.pdf.
    • Note for guidance on the investigation of bioavailability and bioequivalence
  • 10
    • 33645810316 scopus 로고    scopus 로고
    • Ministry of Health Malaysia, DTP Production, Kuala Lumpur, Malaysia
    • Malaysian Guidelines for Good Clinical Practice 1999, Ministry of Health Malaysia, DTP Production, Kuala Lumpur, Malaysia.
    • (1999) Malaysian Guidelines for Good Clinical Practice
  • 11
    • 3042640317 scopus 로고    scopus 로고
    • Bioequivalence trials of rifampicin containing formulations: Extrinsic and intrinsic factors in the absorption of rifampicin
    • Agrawal S, Singh I, Kaur KJ, et al. Bioequivalence trials of rifampicin containing formulations: Extrinsic and intrinsic factors in the absorption of rifampicin. Pharmacol Res. 2004, 50:317-327.
    • (2004) Pharmacol Res. , vol.50 , pp. 317-327
    • Agrawal, S.1    Singh, I.2    Kaur, K.J.3
  • 12
    • 0003484310 scopus 로고    scopus 로고
    • US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM)Center for Veterinary Medicine (CVM), Accessed August 23, 2010
    • Guidance for Industry: Bioanalytical method validation 2001, US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM)Center for Veterinary Medicine (CVM), Accessed August 23, 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf.
    • (2001) Guidance for Industry: Bioanalytical method validation
  • 15
    • 67649970602 scopus 로고    scopus 로고
    • Comparative bioavailability study of two salbutamol tablets in healthy adult volunteers
    • Chik Z, Basu RC, Pendek R, et al. Comparative bioavailability study of two salbutamol tablets in healthy adult volunteers. Int J Pharmacol Ther. 2009, 47:413-418.
    • (2009) Int J Pharmacol Ther. , vol.47 , pp. 413-418
    • Chik, Z.1    Basu, R.C.2    Pendek, R.3
  • 16
    • 28444438937 scopus 로고    scopus 로고
    • Minimum sample size and sampling time requirements for assessment of rifampicin bioequivalence from FDC formulations
    • Agrawal S, Kaur KJ, Singh I, et al. Minimum sample size and sampling time requirements for assessment of rifampicin bioequivalence from FDC formulations. Int J Tuberc Lung Di's. 2005, 9:1273-1280.
    • (2005) Int J Tuberc Lung Di's. , vol.9 , pp. 1273-1280
    • Agrawal, S.1    Kaur, K.J.2    Singh, I.3
  • 18
    • 0020662337 scopus 로고
    • Statistical analysis of bioavailability studies: Parametric and nonparametric con- fidence intervals
    • Steinijans VW, Diletti E Statistical analysis of bioavailability studies: Parametric and nonparametric con- fidence intervals. Eur J Clin Pharma- col. 1983, 24:127-136.
    • (1983) Eur J Clin Pharma- col. , vol.24 , pp. 127-136
    • Steinijans, V.W.1    Diletti, E.2
  • 19
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987, 15:657-680.
    • (1987) J Pharmacokinet Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 20
    • 0037148653 scopus 로고    scopus 로고
    • Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels
    • Agrawal S, Kaur KJ, Singh I, et al. Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels. Int J Pharm. 2002, 233:169-177.
    • (2002) Int J Pharm. , vol.233 , pp. 169-177
    • Agrawal, S.1    Kaur, K.J.2    Singh, I.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.