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Comparative Bioavailability Study of Two Atenolol Tablet Preparations
- Source :
- Drug Development and Industrial Pharmacy. 25:357-360
- Publication Year :
- 1999
- Publisher :
- Informa UK Limited, 1999.
-
Abstract
- A study was conducted to compare the bioavailability of a generic product of atenolol (Normaten FC) with the innovator product, Tenormin. Twelve healthy adult volunteers participated in the study conducted according to a randomized, two-way crossover design. The preparations were compared using area under the plasma concentration-time curve AUC0-infinity, peak plasma concentration Cmax, and time to reach peak plasma concentration Tmax. No statistically significant difference was obtained between the Tmax values and the logarithmic transformed AUC0-infinity and Cmax values of the two products. Moreover, the 90% confidence interval for the ratio of the logarithmically transformed AUC0-infinity values of Normaten FC over those of Tenormin was found to lie between 0.82 and 0.98, while that of the logarithmically transformed Cmax values was between 0.82 and 1.09, both being within the bioequivalence limit of 0.80-1.25. The values of elimination half-life t1/2 between the two products were also found comparable and not significantly different statistically. The t1/2 values obtained in our study were slightly longer than those reported in the literature for other population groups.
- Subjects :
- Adult
Male
Adrenergic beta-Antagonists
Population
Cmax
Biological Availability
Pharmaceutical Science
Bioequivalence
Pharmacology
Animal science
Pharmacokinetics
Drug Discovery
Humans
Medicine
education
education.field_of_study
Cross-Over Studies
business.industry
Organic Chemistry
Atenolol
Crossover study
Confidence interval
Bioavailability
Area Under Curve
business
Tablets
medicine.drug
Subjects
Details
- ISSN :
- 15205762 and 03639045
- Volume :
- 25
- Database :
- OpenAIRE
- Journal :
- Drug Development and Industrial Pharmacy
- Accession number :
- edsair.doi.dedup.....af0200dcfca96dc20f706a7cc8791bb0