203
Views
14
CrossRef citations to date
0
Altmetric
Original

Comparative Crossover, Randomized, Open-Label Bioequivalence Study on the Bioequivalence of Two Formulations of Thioctic Acid in Healthy Volunteers

, , , &
Pages 575-586 | Received 04 Jun 2007, Accepted 27 Jul 2007, Published online: 03 Jul 2009

References

  • Snell EE, Strong FM, Peterson WH. Growth factors for bacteria VI: Fractionation and properties of an accessory factor for lactic acid bacteria. Biochem J 1937; 31: 1789–1799
  • Reed LJ. Multienzyme complexes. Acc Chem Res 1974; 7: 40
  • Packer L, Witt EH, Tritschler HJ. Alpha-lipoic acid as a biological antioxidant. Free Radic Biol Med 1995; 19: 227–250
  • Scholich H, Murphy ME, Sies H. Antioxidant activity of dihydrolipoate against microsomal lipid peroxidation and its dependence on alpha-tocopherol. Biochim Biophys Acta 1989; 1001: 256–261
  • Busse E, Zimmer G, Schopohl B, Kornhuber B. Influence of alpha-lipoic acid on intracellular glutathione in vitro and in vivo. Arzneimittelforschung 1992; 42: 829–831
  • Kagan VE, Serbinova EA, Koynova GM, Kitanova SA, Tyurin VA, Stoytchev TS, Quinn PJ, Packer L. Antioxidant action of ubiquinol homologues with different isoprenoid chain length in biomembranes. Free Radic Biol Med 1990; 9: 117–126
  • Jorg J, Metz F, Scharafinski H. Drug treatment of diabetic polyneuropathy with alpha-lipoic acid or vitamin B preparations. A clinical and neurophysiologic study. Nervenarzt 1988; 59: 36–44
  • Ziegler D, Mayer P, Muehlen H, Gries FA. Effekte einer Therapie mit alpha- Liponsaeure gegenueber Vitamin B1 bei der diabetischen Neuropathie. Diabetes Stoffw 1993; 2: 443
  • Ziegler D, Hanefeld M, Ruhnau KJ, et al. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid. A three-week multicentre randomized controlled trial (ALADIN Study). Diabetologia 1995; 38: 1425–1433
  • Nourooz-Zadeh J, Rahimi A, Tajaddini-Sarmadi J, et al. Relationships between plasma measures of oxidative stress and metabolic control in NIDDM. Diabetologia 1997; 40: 647–653
  • Ziegler D, Schatz H, Conrad F, et al. Effects of treatment with the antioxidant alpha-lipoic acid on cardiac autonomic neuropathy in NIDDM patients. A four-month randomized controlled multicenter trial (DEKAN Study). Deutsche Kardiale Autonome Neuropathie. Diabetes Care 1997; 20: 369–373
  • Ziegler D, Gries FA. Alpha-lipoic acid in the treatment of diabetic peripheral and cardiac autonomic neuropathy. Diabetes 1997; 46: S62–S66
  • Borcea V, Nourooz-Zadeh J, Wolff SP, et al. Alpha-lipoic acid decreases oxidative stress even in diabetic patients with poor glycemic control and albuminuria. Free Radic Biol Med 1999; 26: 1495–1500
  • Haak ES, Usadel KH, Kohleisen M, et al. The effect of alpha-lipoic acid on the neurovascular reflex arc in patients with diabetic neuropathy assessed by capillary microscopy. Microvasc Res 1999; 58: 28–34
  • Rehman A, Nourooz-Zadeh J, Moller W, et al. Increased oxidative damage to all DNA bases in patients with type II diabetes. FEBS Lett 1999; 448: 120–122
  • Ziegler D, Hanefeld M, Ruhnau KJ, et al. Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: A seven-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group Alpha-Lipoic Acid in Diabetic Neuropathy. Diabetes Care 1999; 22: 1296–1301
  • Gleiter CH, Schung BS, Hermann R, Elze M, Blume HH, Guntert-Remy U. Influence of food intake on the bioavailability of thioctic acid enantiomers. Eur J Clin Pharmacaol 1996; 50: 513–514
  • Hermann R, Niebch G, Borbe HO, et al. Enantioselective pharmacokinetics and bioavailability of different racemic alpha-lipoic acid formulations in healthy volunteers. Eur J Clin Pharmacol Sci 1996; 4: 167
  • Teichert J, Kern J, Tritschler HJ, Ulrich H, Preiss R. Investigations on the pharmacokinetics of alpha-lipoic acid in healthy volunteers. Int J Clin Pharmacol Ther 1998; 36: 625–628
  • Breithaupt-Grögler K, Niebch G, Schneider E, et al. Dose-proportionality of oral thioctic acid—coincidence of assessments via pooled plasma and individual data. Eur J Clin Pharmacol Sci 1999; 8: 57–65
  • http://www.idi.it/ric/ce/helsinki.pdf, World Medical Association Declaration of Helsinki. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Available at:
  • Chen J, Jiang W, Cai J, Tao W, Gao X, Jiang X. Quantification of lipoic acid in plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci Sep, 2005; 824: 249–257
  • Hodges JR, Lehmann EL. Annals of Mathematical Statistics 1963; 34: 598–611
  • Phillips KF. Power of the two one-sided tests procedure in bioequivalence. Journal Pharmacokinet Biopharm 1990; 18(2)137–144
  • Sauter R, Steinijans VW, Diletti E, Bohm A, Schulz HU. Presentation of results from bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1992; 30(7)233–256
  • Chow SC, Liu JP. Desigend and Analysis of Bioavailability and Bioequivalence Studies. Marcell Dekker Inc, New York 1992
  • Tschudi MR, Luscher TF. Nitric oxide: The endogenous nitrate in the cardiovascular system. Herz 1996; 21: 50–60
  • Rajagopalan S, Kurz S, Munzel T, Tarpey M, Freeman BA, Griendling KK, Harrison DG. Angiotensin II-mediated hypertension in the rat increases vascular superoxide production via membrane NADH/NADPH oxidase activation. Contribution to alterations of vasomotor tone. J Clin Invest 1996; 97: 1916–1923
  • Noll G, Tschudi M, Nava E, Luscher TF. Endothelium and high blood pressure. Int J Microcirc Clin Exp 1997; 17: 273–279
  • Pechanova O, Kashiba M, Inoue M. Role of glutathione in stabilization of nitric oxide during hypertension developed by inhibition of nitric oxide synthase in the rat. Jpn J Pharmacol 1999; 81: 223–229
  • Zicha J, Dobesova Z, Kunes J. Relative deficiency of nitric oxide-dependent vasodilation in salt-hypertensive Dahl rats: The possible role of superoxide anions. J Hypertens 2001; 19: 247–254
  • Kunes J, Hojna S, Kadlecova M, Dobesova Z, Rauchova H, Vokurkova M, Loukotova J, Pechanova O, Zicha J. Altered balance of vasoactive systems in experimental hypertension: The role of relative NO deficiency. Physiol Res 2004; 53: S23–S34
  • Pechanova O, Rezzani R, Babal P, Bernatova I, Andriantsitohaina R. Beneficial effects of provinols: Cardiovascular system and kidney. Physiol Res 2006; 55: S17–S30
  • de Champlain J, Wu R, Girouard H, Karas M, El Midaoui A, Laplante MA, Wu L. Oxidative stress in hypertension. Clin Exp Hypertens 2004; 26: 593–601
  • Chen X, Touyz RM, Park JB, Schiffrin EL. Antioxidant effects of vitamins C and E are associated with altered activation of vascular NADPH oxidase and superoxide dismutase in stroke-prone SHR. Hypertension 2001; 38: 606–611
  • Chu Y, Iida S, Lund DD, Weiss RM, DiBona GF, Watanabe Y, Faraci FM, Heistad DD. Gene transfer of extracellular superoxide dismutase reduces arterial pressure in spontaneously hypertensive rats: Role of heparin-binding domain. Circ Res 2003; 92: 461–468
  • Kojsova S, Jendekova L, Zicha J, Kunes J, Andriantsitohaina R, Pechanova O. The effect of different antioxidants on nitric oxide production in hypertensive rats. Physiol Res 2006; 55: S3–S16
  • Vasdev S, Ford CA, Parai S, Longerich L, Gadag V. Dietary lipoic acid supplementation prevents fructose-induced hypertension in rats. Nutr Metab Cardiovasc Dis 2000; 10: 339–346
  • Vasdev S, Ford CA, Parai S, Longerich L, Gadag V. Dietary alpha-lipoic acid supplementation lowers blood pressure in spontaneously hypertensive rats. J Hypertens 2000; 18: 567–573
  • Vasdev S, Gill V, Longerich L, Parai S, Gadag V. Salt-induced hypertension in WKY rats: Prevention by alpha-lipoic acid supplementation. Mol Cell Biochem 2003; 254: 319–326
  • Wollin SD, Jones PJ. Alpha-lipoic acid and cardiovascular disease. J Nutr Nov, 2003; 133: 3327–3330
  • Holmquist L, Stuchbury G, Berbaum K, Muscat S, Young S, Hager K, Engel J, Munch G. Lipoic acid as a novel treatment for Alzheimer's disease and related dementias. Pharmacol Ther Jan, 2007; 113: 154–164
  • Pershadsingh HA. Alpha-lipoic acid: Physiologic mechanisms and indications for the treatment of metabolic syndrome. Expert Opin Investig Drugs Mar, 2007; 16: 291–302

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.