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 AUC0-∞ with means±SD of 31.71±7.85, 30.88±10.28 (μg/L) respectively for treatments B and A, the ratio (FB/A) was of 1.1 with 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 AUC0-∞ 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 option for treating HIV-infected patients with swallowing disturbances or compliance problems.
| Original language | English |
|---|---|
| Pages (from-to) | 569-574 |
| Number of pages | 6 |
| Journal | Journal of Chemotherapy |
| Volume | 13 |
| Issue number | 5 |
| Publication status | Published - 2001 |
Keywords
- HAART
- Highly active antiretroviral therapy
- HIV therapy
- Nelfinavir
- Protease inhibitors
ASJC Scopus subject areas
- Pharmacology (medical)
- Microbiology (medical)