Bioequivalence study of levothyroxine tablets compared to reference tablets and an oral solution

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 10, 2004, Pages 680-684

  Koytchev, Rossen ^a,c   Lauschner, Reinhard ^b  

^a Coop Clin Drug Res and Devmt ^*  (Germany)

^b Lindopharm GmbH   (Germany)

^c CCDRD AG   (Germany)

Author keywords

CAS 51 48 9; Eferox ; Levothyroxine, bioequivalence, clinical pharmacokinetics, oral solution, tablets

Indexed keywords

IODINE 125; LEVOTHYROXINE SODIUM; LIOTHYRONINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASPHYXIA; BIOEQUIVALENCE; CERVICAL SPINE INJURY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG SOLUTION; DRY SKIN; FEMALE; FEVER; FLU LIKE SYNDROME; GINGIVITIS; HEADACHE; HUMAN; HUMAN EXPERIMENT; HYPEREMIA; ISOTOPE LABELING; LIOTHYRONINE BLOOD LEVEL; MALE; NERVOUSNESS; NORMAL HUMAN; PETECHIA; PHARYNX DISEASE; RADIOIMMUNOASSAY; RANDOMIZED CONTROLLED TRIAL; SCAR; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; SPRAIN; TABLET;

EID: 7044264219     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297021     Document Type: Article

References (10)

1. Mandel, S., Brent, G., Larsen, R., Levothyroxine therapy in patients with thyroid disease. Arch. Intern. Med. 119, 492 (1993)
2. IMS America Ltd., National prescription audit. Basis data report. Ambler, Pennsylvania (1988)
3. Wartofsky, L., Levothyroxine: therapeutic use and regulatory issues related to bioequivalence. Expert Opin. Pharmacother. 3, 727 (2002)
4. Klein, I., Evaluation of the therapeutic efficacy of different levothyroxine preparations in the treatment of human thyroid disease. Thyroid 13, 1127 (2003)
5. Fish, L. H., Schwartz, H. L., Cavanaugh, J. et al., Replacement dose, metabolism, and bioavailability of levothyroxine in the treatment of hypothyroidism. Role of triiodothyronine in pituitary feedback in humans. N. Engl. J. Med. 316, 764 (1987)
6. Read, D., Hays, M. T., Hershman, J. M., Absorption of oral thyroxine in hypothyroid and normal man. J. Clin. Endocrinol. Metab. 30, 798 (1970)
7. Wennlund, A., Variation in serum levels of T3, T4, FT4, and TSH during thyroxine replacement therapy. Acta Endocrinol. (Copenh.) 113, 47 (1986)
8. Browning, M. C., Bennet, W. M., Kirkaldy, A. J. et al., Intra-individual variation of thyroxin, triiodothyronine, and thyrotropin in treated hypothyroid patients: implications for monitoring replacement therapy. Clin. Chem. 34, 696 (1988)
9. CPMP Note for guidance: Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 (1998)
10. Gottwald, R., Lorkowski, G., Petersen, G. et al., Bioequivalence of two commercially available levothyroxine-Na preparations in athyreotic patients. Methods Find. Exp. Pharmacol. 16, 645 (1994)