Clinical Comparative Bioavailability Study of ICN- and Roche-Manufactured 30 mg Pyridostigmine Bromide Tablets in Healthy Volunteers

Abstract

Pyridostigmine Bromide 30 mg tablets manufactured by ICN Canada and Roche UK were studied in a two treatment, crossoverdesign bloavailability study. Plasma samples obtained from the 30 healthy subjects that completed the study were analyzed using a validated LC/MS/MS method and concentrations were used to determine bioequivalence. The products were found to be bioequivalen based upon the 90% confidence intervals of the logarithmically transformed AUC 0-T, AUC 0-Infinity and CMAX. The confidence intervals surrounding the ratios of test versus reference means were within the 0.80 to 1.25 bioequivalence limits.

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Document Details

Document Type
Technical Report
Publication Date
Sep 01, 2001
Accession Number
ADB270791

Entities

People

  • Michael Garvin
  • Ronald Goldwater
  • Sandra Braun

Tags

DTIC Thesaurus Topics

  • Abstracts
  • Analysis Of Variance
  • Biomedical Research
  • Classification
  • Data Science
  • Electronic Mail
  • Governments
  • Information Operations
  • Information Science
  • Intervals
  • Maryland
  • Pyridostigmine Bromide
  • Security
  • Statistical Analysis
  • Technical Information Centers
  • Volunteers

Fields of Study

  • Medicine

Readers

  • Oncology and Biomarker-Based Cancer Detection.
  • Statistical inference.
  • Toxicology/Environmental Toxicology