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Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide

  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Cheryl D. Blume
    Correspondence
    Requests for reprints should be addressed to Dr. Cheryl D. Blume, Pharmacokinetic and Clinical Study Programs and Regulatory Affairs, Mylan Pharmaceuticals, Incorporated, Box 4310, Morgantown, West Virginia 26505.
    Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Affiliations
    Morgantown, West Virginia, USA
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  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Roger L. Williams
    Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Affiliations
    San Francisco, California, USA
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  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Robert A. Upton
    Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Affiliations
    San Francisco, California, USA
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  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Emil T. Lin
    Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Affiliations
    San Francisco, California, USA
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  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Leslie Z. Benet
    Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
    Affiliations
    San Francisco, California, USA
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  • Author Footnotes
    1 From Mylan Pharmaceuticals, Incorporated, Morgantown,West Virginia, and the Drug Studies Unit, University of California, San Francisco, California.
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      A three-treatment, single-dose, crossover bioequivalence study was conducted in healthy volunteers to compare urinary drug recovery following administration of hydrochlorothiazide tablets, the currently marketed capsule formulation of triamterene and hydrochlorothiazide (Dyazide), and a new tablet preparation of these active ingredients (Maxzide). No significant differences were observed in the urinary recovery of hydrochlorothiazide after the administration of hydrochlorothiazide tablets and Maxzide tablets. However, only about one-half as much hydrochlorothiazide was recovered following the administration of Dyazide capsules. Similarly, the urinary recovery of triamterene and the sulfate ester of hydroxy-triamterene after administration of Dyazide capsules was approximately one-half the levels observed after giving the new tablet formulation. The clinical consequences of the limited bioavailability of the active ingredients of Dyazide are discussed.
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