Accession Number:

ADB270791

Title:

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

Descriptive Note:

Final rept. 4 Aug 2000-30 Sep 2001

Corporate Author:

PHARMAKINETICS LABORATORIES INC BALTIMORE MD

Report Date:

2001-09-01

Pagination or Media Count:

14.0

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 LCMSMS 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.

Subject Categories:

  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE