Bioequivalence Clinical Trial
Official title:
An Open Label, Two Treatment, Two Period, Two Sequence,Crossover, Bioequivalence Study of BH009 Against Winthrop (Docetaxel) Injection in Patients With Solid Tumors
The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II)
46 patients will be enrolled in the study. The dosing schedule will be as follows: Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product) on the first day of the chemotherapy cycle. Period II (Day 22): Patients will be crossover to another treatment arm to receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product depending of crossover sequence) on the first day of the next chemotherapy cycle. A total of 17 blood samples for PK assessment will be collected during each period. The pre-infusion blood sample of 06 mL (0.000 hr) will be collected within 5 minutes prior to start of infusion. On Day 1 (Period I) and Day 22# (Period II): The blood samples of 06 mL each will be drawn at 0.500 (30 minutes), 0.667 (40 minutes) and 0.833 (50 minutes) during infusion, 1.000 hour* (immediately at the actual end of infusion), and at 0.083 (5 minutes), 0.167 (10 minutes), 0.333 (20 minutes), 0.500 (30 minutes), 1.000, 2.000, 3.000, 6.000, 8.000, 12.000, 24.000 and 48.000 hours after the end of the docetaxel infusion. Employing the estimated concentration time profiles of Unbound Docetaxel & Total Docetaxel following variables will be calculated: Primary variables: Cmax, AUC0-t and AUC0-∞ Secondary variable: Tmax, t1/2, Kel, Vd, CL and AUC_%Extrap_obs Criteria for evaluation: For Unbound Docetaxel & Total Docetaxel, based on the statistical results of 90% confidence intervals for the geometric least square mean ratio (T/R) for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, conclusions will be drawn whether test formulation is bioequivalent to reference formulation. Acceptance range for bioequivalence is 80.00% - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R) for Cmax, AUC0-t and AUC0-∞. ;
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