Bioequivalence study of two nevirapine tablet formulations in human-immunodeficiency-virus-infected patients.
OBJECTIVE
The present study describes the determination of the bioequivalence of two different nevirapine tablet formulations (nevirapine tablets 200 mg, Novatec, as the test formulation vs. viramune tablets 200 mg, Boehringer Ingelheim, as the reference formulation).


METHODS
A single 200 mg oral dose of each preparation was administered to 11 human immunodeficiency virus (HIV)-infected patients volunteers and their bioequivalence was assessed by comparing the both plasma nevirapine concentrations-time curves and others pharmacokinetic parameters.


RESULTS
The pharmacokinetic parameters obtained for each formulation were the area under the time-concentration curve from 0 to 12 h (AUC(0-12)) and from 0 to infinity (AUC(0-infinite)), maximum concentration (C(max)), and the time at which it occurred (T(max)). These parameters were determined by high-performance liquid chromatography (HPLC). No significant differences were observed in these parameters. The 90% confident interval for the ratio of means for the lnAUC(0-12 T/R) (0.92-1.10), lnAUC(0-infinite T/R) (0.86-1.17) and lnC(max T/R) (0.71-1.38) are within the guideline range of bioequivalence (0.80 to 1.25 and 0.70 to 1.43). For T(max) the mean of test formulation is in the range 2.64 +/- 0.53 h.


CONCLUSIONS
The results show that the formulations were bioequivalent in the extent and in the rate of absorption.
Tarinas
A
A
Clinical Pharmacology Lab, Pedro Kouri Institute, Havana, Cuba. ali@ipk.sld.cu
Tápanes
R D
RD
González
D
D
Ferrer
G
G
Abreu
D
D
Pérez
J
J
D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D013607:Tablets; D013810:Therapeutic Equivalency
D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D013607:Tablets; D019829:Nevirapine