Pharmacokinetics and comparative bioavailability of two vinpocetine tablet formulations in healthy volunteers by using the metabolite apovincaminic acid as pharmacokinetic parameter

Arzneimittel-Forschung/Drug Research

Volumn 55, Issue 11, 2005, Pages 664-668

  Vlase, Laurian ^a   Bodiu, Bogdan ^b   Leucuta, Sorin E ^a  

^a IULIU HATIEGANU UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^b Institute of Cardiology   (Romania)

Author keywords

Apovincaminic acid; CAS 42971 09 5; Nootropic; Vimpocetina ; Vinpocetine, bioavailability, bioequivalence, pharmacokinetics

Indexed keywords

APOVINCAMINIC ACID; DRUG METABOLITE; VIMPOCETINA; VINPOCETINE;

ACCURACY; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG RELEASE; FRIEDMAN TEST; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MASS SPECTROMETRY; NORMAL HUMAN; RELIABILITY; SINGLE DRUG DOSE; TABLET; VALIDATION PROCESS;

EID: 28744432574     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296915     Document Type: Article

References (18)

1. Hadjiev, D., Yancheva, S., Rheoencephalographic and psychological studies with ethyl apovincaminate in cerebral vascular insufficiency. Arzneim.-Forsch./Drug Res. 26, 1947 (1976)
2. Karpati, E., Szporny, L., General and cerebral haemodynamic activity of ethyl apovincaminate. Arzneim.-Forsch./Drug Res. 26, 1908 (1976)
3. Ribári, O., Zelen, B., Kollár, B., Ethyl apovincaminate in the treatment of sensorineural impairment of hearing. Arzneim.-Forsch./Drug Res. 26, 1977 (1976)
4. Szobor, A., Klein, M., Ethyl apovincaminate therapy in neurovascular disease. Arzneim.-Forsch./Drug Res. 26, 1984 (1976)
5. Tamaki, N., Kusunoki, T., Matsumoto, S., The effect of vinpocetine on cerebral blood flow in patients with cerebrovascular disordes. Ther. Hung. 33, 13 (1985)
6. Kiss, B., Karpati, E., Mechanism of action of vinpocetine. Acta Pharm. Hung. 66, 213 (1996)
7. v1.8 Tetrodotoxin-Resistant Sodium Channels. J. Pharmacol. Exp. Ther. 306, 498, 2003.
8. Miskolczi, P., Vereczkey, L., Szalay, L. et al., Effect of age on the pharmacokinetics of vinpocetine (Cavinton) and apovincaminic acid. Eur. J. Clin. Pharmacol. 33, 185 (1987)
9. Vereczkey, L., Czira, G., Tamas, J. et al., Pharmacokinetics of vinpocetine in humans. Arzneim.-Forsch./Drug Res. 29, 957 (1979)
10. Grandt, R., Beitinger, H., Schaltenbrand, R. et al., Vinpocetine pharmacokinetics in elderly subjects. Arzneim.-Forsch./Drug Res. 39, 1599, (1989)
11. Szakacs, T., Veres, Zs., Vereczkey, L., In vitro-in vivo correlation of the pharmacokinetics of vinpocetine. Pol. J. Pharmacol. 53, 623 (2001)
12. Vereczkey, L., Pharmacokinetics and metabolism of vincamine and related compounds. Eur. J. Drug Metab. Pharmacokinet. 10, 89 (1985)
13. Miskolczi, P., Kozma, K., Polgar, M. et al., Pharmacokinetics of vinpocetine and its main metabolite apovincaminic acid before and after the chronic oral administration of vinpocetine to humans. Eur. J. Drug Metab. Pharmacokinet. 15, 1 (1990)
14. Maya, M. T., Pais, J. P., Araujo, H. M. et al., Determination of apovincaminic acid in human plasma by high-performance liquid chromatography. J. Pharm. Biomed. Anal. 14, 617 (1996)
15. Midha, K. K., Rawson, M. J., Hubbard, J. W., The role of metabolites in bioequivalence. Pharm. Res. 21, 1331 (2004)
16. The European Agency for the Ealuation of Medicinal Products, Committee for proprietary medicinal products. Note for guidance on the investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98, London, 26 July 2001
17. U. S. Department of Helath and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Bioavailability and Bioequivalence studies for orally administered drug products-general considerations, July 2002
18. Schuirmann, D. J., A comparison of the two one-side test procedure and the power approach for assessment of the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15, 657(1987)