A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours
Status:
Completed
Trial end date:
2021-09-24
Target enrollment:
Participant gender:
Summary
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)