Bioequivalence study to compare Xeloda and Capecitabine tablets in patients with colorectal cancer or breast cancer

Intervention1: Capecitabine (CJSC Biocad) tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Capecitabine will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Control Intervention1: Xeloda (Capecitabine)tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Xeloda will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Primary outcome(s): Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug:
Area under capecitabine «concentration-time» curve at the time of the drug administration up to 12 hours (AUC(0-12))
Timepoint: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label