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European Journal of Clinical Pharmacology

, Volume 26, Issue 2, pp 261–264 | Cite as

Bioequivalence studies in humans of indomethacin capsules marketed in India

  • G. N. Chaudhari
  • H. P. Tipnis
  • B. S. Doshi
  • R. D. Kulkarni
Originals

Summary

Two, separate 6×6 Latin square cross-over bioequivalence studies were performed in adult male volunteers using 10 different indomethacin capsule preparations marketed in India together with the pure drug powder as the standard. The products were evaluated with respect to plasma level at various times up to 8 h following administration of a 50 mg (2 × 25 mg) dose. Plasma samples were analysed by a fluorimetric method. Various pharmacokinetic parameters were calculated according to a two compartment model. Statistical evaluation of the data employed analysis of variance for a cross-over design (ANOVA) and Duncan's multiple range test to ascertain the significance of differences between the products. Of the 10 products studied, two were found to be bioinequivalent.

Key words

indomethacin capsules bioequivalence volunteers pharmacokinetics statistical significance bioavailability comparative bioequivalence 

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Copyright information

© Springer-Verlag 1984

Authors and Affiliations

  • G. N. Chaudhari
    • 1
  • H. P. Tipnis
    • 1
  • B. S. Doshi
    • 2
  • R. D. Kulkarni
    • 2
  1. 1.The Bombay College of PharmacyBombayIndia
  2. 2.Department of Clinical PharmacologyGrant Medical CollegeBombayIndia

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