Guelen PJ, Stevenson D, Briggs RJ, de Vos D
The bioavailability of Tamoplex (tamoxifen). Part 2. A single dose cross-over study in healthy male volunteers. [Journal Article]
Methods Find Exp Clin Pharmacol 1987 Oct; 9(10):685-90.
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.
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