Bioequivalence of two commercially available tamoxifen tablet formulations in healthy male volunteers

Tamoxifen, a non-steroidal antiestrogen, is used in the palliative treatment of advanced breast cancer and as an adjuvant therapy after mastectomy. The bioequivalence of tamoxifen following single oral doses of Zemide® 20 and a commercially available tablet formulation (reference formulation), each containing 30.4 mg tamoxifen dihydrogencitrate corresponding to 20 mg tamoxifen was investigated in 12 healthy male subjects. In a randomized, crossover study with a washout period of 13 weeks the volunteers received one pharmaceutical unit of both formulations after an overnight fast on an empty stomach