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PHARMACOKINETIC AND BIOEQUIVALENCE COMPARISON BETWEEN CAPSULES OF ATAZANAVIR SULFATE 300MG: AN OPEN LABEL, BALANCED, RANDOMIZED-SEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY INDIAN MALE VOLUNTEERS
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| Author:
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NIDAMANURI DEVI, SRIDEVI, SUVARCHALA PATCHALA
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| Abstract:
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Bioavailability (BA) and bioequivalence (BE) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. BE is a strategy to introduce generic equivalents of brand-name drugs (innovator drugs) to lower the cost of medication through proper assessment as directed by the international regulatory authorities. Concern about lowering health care costs has resulted in a tremendous increase in the use of generic drug products. Thus, Bioavailability and Bioequivalence of drug products, and drug product selection have emerged as critical issues in pharmacy and medicine during the last three decades. This present bioequivalence study was designed to determine the bioavailability and bioequivalence of atazanavir sulfate 300 mg capsules in comparison with Reyataz® 300mg capsules after single dose administration under fasting conditions in healthy adult male Indian subjects. Therefore the design of an open label, balanced, randomized, single dose, two-treatment, two-sequence, two-period crossover study with a wash-out period of at least 5 days was used.
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| Keyword:
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Bioequivalence, Pharmacokinetics, Atazanavir Sulfate, Reyataz
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| EOI:
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| DOI:
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| Download:
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Request For Article
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