A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
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)
Epistemonikos ID: e28c84fcd90cd7eb9bfac4266b921b14e246a270
First added on: May 08, 2024