A bioequivalence study of Levothyroxine tablets versus an oral Levothyroxine solution in healthy volunteers

Probably for genetic reasons a substantial part of the Greek population requires Levothyroxine treatment. Since commercially available Levothyroxine was first marketed, the manufacture and storage of the drug in tablet form has been complicated and difficult; and as cases of therapeutic failure have...

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Bibliographic Details
Published in:European journal of drug metabolism and pharmacokinetics 2006-04, Vol.31 (2), p.73-78
Main Authors: YANNOVITS, N, ZINTZARAS, E, BENAKIS, A, POULI, A, KOUKOULIS, G, LYBERI, S, SAVARI, E, POTAMIANOS, S, TRIPOSKIADIS, F, STEFANIDIS, I, ZARTALOUDIS, E
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Biological and medical sciences
Hormones. Endocrine system
Humans
Immunoassay - methods
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Reproducibility of Results
Solutions
Tablets
Therapeutic Equivalency
Thyrotropin - blood
Thyroxine - administration & dosage
Thyroxine - blood
Thyroxine - pharmacokinetics
Triiodothyronine - blood
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Summary:Probably for genetic reasons a substantial part of the Greek population requires Levothyroxine treatment. Since commercially available Levothyroxine was first marketed, the manufacture and storage of the drug in tablet form has been complicated and difficult; and as cases of therapeutic failure have frequently been reported following treatment with this medicinal agent, quality control is an essential factor. Due to the unreliability of Levothyroxine-based commercial products, in the present study we decided to follow the Food and Drug Administration (FDA) guidelines*, and use a Levothyroxine solution as reference product. The bioavailability of the Levothyroxine sodium tablet formulation THYROHORMONE/Ni-The Ltd (0.2 mg/tab) and that of a reference oral solution (0.3 mg/100 ml) under fasting conditions were compared in an open, randomized, single-dose two-way crossover study. Twenty four healthy Caucasian volunteers (M/F=15/9, mean age=32.9+/-7.4yr) participated in the study. Bioavailability was assessed by pharmacokinetic parameters such as the area under plasma concentration-time curve from time zero up to the measurable last time point (AUC(last)) and the maximum plasma concentration (Cmax). Heparinized venous blood samples were collected pre-dose and up to a 48-hour period post-dose. Levothyroxine sodium in plasma samples was assayed by a validated electrochemiluninescent immunoassay technique. Statistical analysis showed that the post-dose thyrotropin-stimulating hormone (TSH) levels decreased significantly (p
ISSN:0378-7966
2107-0180
DOI:10.1007/BF03191122