Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében

Translated title of the contribution: Clinical pharmacological study of panomifene in accordance with the pharmacokinetic results

Erdelyi Toth Valeria, Gyergyay Fruzsina, Pap Eva, Szamel Iren, Kralovanszky Judit, Bojti Erzsebet, Klebovich Imre

Research output: Contribution to journalArticle

Abstract

Objectives: Panomifene, PAN, /E/-1, 2-diphenyl-1-14-12-(2-hydroxyethy- amino)-ethoxyl-phenyl1-3, 3, 3-trifluoropropene is a new original Hungarian compound, structurally similar to tamoxifen, TMX. In the human phase l/a study the human tolerance, pharmacokinetics and endocrine effects of a single oral dose of PAN were evaluated in healthy, postmenopausal, female volunteers. The present paper describes the clinical pharmacokinetics of the drug. Methods: In the course of the dose escalation detailed pharmacokinetic studies were carried out at doses of 24, 48, 96 mg in two volunteers, 120 mg in one volunteer. At a selected dose level (24 mg) detailed pharmacokinetics were performed in 10 volunteers. Results: The pharmacokinetic study showed considerable interindividual variability of the parameters, the kinetics, however, was linear in the studied dose range. At the selected dose level (24 mg p. o.) the peak concentration of the plasma was 61,25±21,71 ng/ml, the time to peak was 3,33±1,68 hours. The mean of the terminal half-life was 71,97±23,64 hours, the area under the plasma concentration time curve (ALJC0-∞) 4007±1405 (nglml)x hours. Conclusions: According to the phase l/a study, the PAN seemed to be a safe TMX analogue, the single oral dose of which did not exert any noteworthy toxic side effect.

Original languageHungarian
Pages (from-to)86-89
Number of pages4
JournalMagyar Onkologia
Volume41
Issue number2
Publication statusPublished - 1997

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Pharmacokinetics
Pharmacology
Volunteers
Poisons
Tamoxifen
Half-Life
Clinical Studies
panomifene
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Oncology

Cite this

Valeria, E. T., Fruzsina, G., Eva, P., Iren, S., Judit, K., Erzsebet, B., & Imre, K. (1997). Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében. Magyar Onkologia, 41(2), 86-89.

Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében. / Valeria, Erdelyi Toth; Fruzsina, Gyergyay; Eva, Pap; Iren, Szamel; Judit, Kralovanszky; Erzsebet, Bojti; Imre, Klebovich.

In: Magyar Onkologia, Vol. 41, No. 2, 1997, p. 86-89.

Research output: Contribution to journalArticle

Valeria, ET, Fruzsina, G, Eva, P, Iren, S, Judit, K, Erzsebet, B & Imre, K 1997, 'Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében', Magyar Onkologia, vol. 41, no. 2, pp. 86-89.
Valeria ET, Fruzsina G, Eva P, Iren S, Judit K, Erzsebet B et al. Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében. Magyar Onkologia. 1997;41(2):86-89.
Valeria, Erdelyi Toth ; Fruzsina, Gyergyay ; Eva, Pap ; Iren, Szamel ; Judit, Kralovanszky ; Erzsebet, Bojti ; Imre, Klebovich. / Panomifene klinikai farmakológiai vizsgálata a farmakokinetikai eredmények tükrében. In: Magyar Onkologia. 1997 ; Vol. 41, No. 2. pp. 86-89.
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abstract = "Objectives: Panomifene, PAN, /E/-1, 2-diphenyl-1-14-12-(2-hydroxyethy- amino)-ethoxyl-phenyl1-3, 3, 3-trifluoropropene is a new original Hungarian compound, structurally similar to tamoxifen, TMX. In the human phase l/a study the human tolerance, pharmacokinetics and endocrine effects of a single oral dose of PAN were evaluated in healthy, postmenopausal, female volunteers. The present paper describes the clinical pharmacokinetics of the drug. Methods: In the course of the dose escalation detailed pharmacokinetic studies were carried out at doses of 24, 48, 96 mg in two volunteers, 120 mg in one volunteer. At a selected dose level (24 mg) detailed pharmacokinetics were performed in 10 volunteers. Results: The pharmacokinetic study showed considerable interindividual variability of the parameters, the kinetics, however, was linear in the studied dose range. At the selected dose level (24 mg p. o.) the peak concentration of the plasma was 61,25±21,71 ng/ml, the time to peak was 3,33±1,68 hours. The mean of the terminal half-life was 71,97±23,64 hours, the area under the plasma concentration time curve (ALJC0-∞) 4007±1405 (nglml)x hours. Conclusions: According to the phase l/a study, the PAN seemed to be a safe TMX analogue, the single oral dose of which did not exert any noteworthy toxic side effect.",
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AU - Fruzsina, Gyergyay

AU - Eva, Pap

AU - Iren, Szamel

AU - Judit, Kralovanszky

AU - Erzsebet, Bojti

AU - Imre, Klebovich

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