The bioavailability of Tamoplex (tamoxifen). Part 2. A single dose cross-over study in healthy male volunteers.
Tamoxifen and N-desmethyltamoxifen plasma concentrations were determined in a single dose cross-over study with Tamoplex and Nolvadex at the dose height of 40 mg in 18 healthy male volunteers with a wash-out period of at least 140 days. ANOVA, power analysis and novel bioequivalence tests on AUC, Cmax and tcmax, including a non-parametric one, demonstrated bioequivalence of Tamoplex and Nolvadex 10 mg tablets. The mean AUC ( +/- SD) values of tamoxifen after administration of Tamoplex or Nolvadex tablets were 1076 +/- 265 and 1131 +/- 301 h ng ml-1, respectively. ANOVA on the AUC values gave a p value of 0.450 with a power of 0.85 and a 95% confidence interval of 81.8-108.5% was obtained. The 0.8 power test showed a determined difference of 18.9%, whereas the actual difference was 4.9%. Interindividual and intraindividual variation was assessed. The pharmacokinetic data, well established for 34 hr, constitute a basis for further studies on tamoxifen distribution, elimination and metabolism.
Guelen
P J
PJ
Farma Research B.V., Ravenstein, The Netherlands.
Stevenson
D
D
Briggs
R J
RJ
de Vos
D
D
D000328:Adult; D001682:Biological Availability; D006801:Humans; D008297:Male; D012016:Reference Values; D013629:Tamoxifen / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D013629:Tamoxifen; C028787:N-desmethyltamoxifen