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The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Levothyroxine Sodium Tablets 200 mg, Synthroid Tablets 200 mg
PRACS Institute, Ltd.
Published on BioPortfolio: 2014-08-27T03:31:42-0400
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 30...
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Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
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