Document Detail


Bioequivalence assessment of two different tablet formulations of diltiazem after single and repeated doses in healthy subjects.
MedLine Citation:
PMID:  10216812     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The study was performed on 14 healthy volunteers in order to compare the pharmacokinetics and hence assess the bioequivalence of two different tablet formulations of diltiazem administered orally. The study was carried out after single doses (60 mg) and repeated doses (60 mg three times a day for six days and 60 mg on the seventh day) according to a randomised, cross-over, open design. The pharmacokinetic parameters AUC0-infinity (ng h/ml), Tmax(h) and Cmax (ng/ml) were calculated for the two formulations after a single dose, while AUCt1-t2 (= AUC for a repetitive dose interval or dosing cycle, ng h/ml) and PTF (peak trough fluctuation) were calculated after repeated doses. The bioequivalence assessment was the shortest 90% confidence interval for the ratio (difference) of expected medians in the respective bioequivalence range (0.80-1.20). The results of this study show that, after either a single dose or repeated doses of test or reference formulations of diltiazem, the pharmacokinetics of the two formulations are similar. The ratios of AUC on day 1 (for single-dose treatment) and on day 7 (for repeated-dose treatment), and the corresponding 90% confidence intervals demonstrate bioequivalence between the two formulations of diltiazem within the accepted range of 0.80-1.20 (80-120%).
Authors:
A Loffreda; M G Matera; C Vacca; G Motola; D De Santis; A Ruggiero; F Russo; F Fici; V Cantoni; E Lampa; F Rossi
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Current medical research and opinion     Volume:  15     ISSN:  0300-7995     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  1999  
Date Detail:
Created Date:  1999-06-22     Completed Date:  1999-06-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  53-61     Citation Subset:  IM    
Affiliation:
Pharmacology and Toxicology Institute, Medical School, Second University of Naples, Italy.
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MeSH Terms
Descriptor/Qualifier:
Adult
Analysis of Variance
Biological Availability
Calcium Channel Blockers / administration & dosage,  pharmacokinetics*
Chemistry, Pharmaceutical
Cross-Over Studies
Diltiazem / administration & dosage,  pharmacokinetics*
Female
Humans
Male
Middle Aged
ROC Curve
Statistics, Nonparametric
Tablets
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Calcium Channel Blockers; 0/Tablets; 42399-41-7/Diltiazem

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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