Document Detail


Comparative bioavailability of different formulations of levothyroxine and liothyronine in healthy volunteers.
MedLine Citation:
PMID:  17259789     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the relative bioavailability of T4 sodium and liothyronine sodium (T3), administered in single doses as oral solution (drops) and tablet forms, according to two separate study protocols. METHODS: Twenty-four healthy, male volunteers were included in both studies. Two test drugs containing T4 or T3 (T4-Ibsa and T3-Ibsa, respectively) were compared to two reference drugs, ie Eutirox 100 and Ti-tre tablets, respectively. A single oral dose of 100 microg (1 ml or 1 tablet) of T4 and 20 microg (1 ml or 1 tablet) of T3 were administered with an open, randomized, crossover design. T4 and T3 serum concentrations were determined by a validated immunoassay in electro-chemo-luminescence method. RESULTS: Study 1: after administration of T4-Ibsa oral solution, Cmax was 14.26+/-0.61 microg/dl, AUC0-t was 282.70 +/-14.29 microg/dl/h, Tmax was 2.71+/-0.25 h. After administration of Eutirox 100 tablets, Cmax was 14.34+/-0.59 microg/dl, AUC0-t was 279.42+/-9.59 microg/dl/h and Tmax was 2.65+/-0.23 h. The 90% confidence interval ratios between test/reference drugs were 1.01 for AUC0-t and 0.99 for Cmax. Study 2: after administration of T3-Ibsa oral solution, Cmax was 3.19+/-0.25 ng/ml, AUC0-t was 44.79+/-2.15 ng/ml/h and Tmax was 2.31+/-0.25 h. After administration of Ti-tre tablets, Cmax was 3.16+/-0.23 ng/ml, AUC0-t was 45.19+/-2.19 ng/ml/h and Tmax was 2.44+/-0.34 h. The 90% confidence interval ratios between test /reference drugs were 0.99 for AUC0-t and 1.01 for Cmax. CONCLUSIONS: The bioavailability of the two oral solutions (T4-Ibsa and T3-Ibsa oral solutions) and the corresponding tablet forms (Eutirox 100 and Ti-tre tablets) were confirmed and they can be considered bioequivalent and therapeutically interchangeable.
Authors:
G M Leggio; T Incognito; G Privitera; M R Marano; F Drago
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of endocrinological investigation     Volume:  29     ISSN:  1720-8386     ISO Abbreviation:  J. Endocrinol. Invest.     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2007-01-29     Completed Date:  2007-02-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7806594     Medline TA:  J Endocrinol Invest     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  RC35-8     Citation Subset:  IM    
Affiliation:
Department of Experimental and Clinical Pharmacology, University of Catania, Viale A. Doria 6, 95125 Catania, Italy.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Biological Availability
Cross-Over Studies
Humans
Male
Middle Aged
Solutions
Tablets
Thyroxine / blood,  pharmacokinetics*
Triiodothyronine / blood,  pharmacokinetics*
Chemical
Reg. No./Substance:
0/Solutions; 0/Tablets; 6893-02-3/Triiodothyronine; 7488-70-2/Thyroxine

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


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