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Titolo:
Nelfinavir suspension obtained from nelfinavir tablets has equivalent pharmacokinetic profile
Autore:
Regazzi, MB; Seminari, E; Villani, P; Carriero, PL; Montagna, M; Marubbi, F; Maserati, R;
Indirizzi:
Univ Pavia, Dept Infect Dis, IRCCS, Policlin San Matteo, I-27100 Pavia, Italy Univ Pavia Pavia Italy I-27100 Policlin San Matteo, I-27100 Pavia, Italy
Titolo Testata:
JOURNAL OF CHEMOTHERAPY
fascicolo: 5, volume: 13, anno: 2001,
pagine: 569 - 574
SICI:
1120-009X(200110)13:5<569:NSOFNT>2.0.ZU;2-Y
Fonte:
ISI
Lingua:
ENG
Soggetto:
HIV; LIQUID; PLASMA;
Keywords:
nelfinavir; protease inhibitors; HIV therapy; HAART; highly active antiretroviral therapy;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
15
Recensione:
Indirizzi per estratti:
Indirizzo: Maserati, R Univ Pavia, Dept Infect Dis, IRCCS, Policlin San Matteo, VialeTaramelli 5, I-27100 Pavia, Italy Univ Pavia Viale Taramelli 5 Pavia Italy I-27100 Pavia, Italy
Citazione:
M.B. Regazzi et al., "Nelfinavir suspension obtained from nelfinavir tablets has equivalent pharmacokinetic profile", J CHEMOTHER, 13(5), 2001, pp. 569-574

Abstract

The pharmacokinetics of nelfinavir tablets (A) and an oral simplified nelfinavir suspension (B) were studied. Twelve healthy volunteers randomly received either five 250-mg nelfinavir tablets or a simplified oral suspension obtained from tablets dissolved in water (nelfinavir 1250 mg in 100 mL of water) in a single dose before being crossed over to the second treatment after a one-week washout period. Blood samples were drawn up to 24 h after drug administration. Nelfinavir concentrations in plasma were analyzed by a specific and validated reverse-phase high-performance liquid chromatography assay (HPLC with UV detection, and pharmacokinetic values were determined. For the AUC(0-infinity) with means +/- SD of 31.71 +/- 7.85, 30.88 +/- 10.28 (mug/L) respectively for treatments B and A, the ratio (F-B/A) was of 1.1with a C.I. of 0.90-1.24. For Cmax with means +/- SD of 3.1 +/- 0.6 (treatment B) and 3.2 +/- 0.8 mg/mL (treatment A), the ratio was 1.0. with C.I. of 0.92-1.08. The two treatments evidenced no significant differences in AUC(0-infinity) and Cmax values and the two-one sided t-test showed that the two preparations are bioequivalent. There was no significant difference in Tmax between the liquid and tablets. Nelfinavir suspension might be a optionfor treating HIV-infected patients with swallowing disturbances or compliance problems.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/06/20 alle ore 02:24:26