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A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours

NCT04889599 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-01-11

No results posted yet for this study

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)

Conditions

Interventions

DRUG

BH009 (Docetaxel injection)

75mg/m2

DRUG

Docetaxel injection

75mg/m2

Sponsors & Collaborators

  • Zhuhai Beihai Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Gopichand M, Ph. D. · HCG City Cancer center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2021-09-17
Completion
2021-09-24
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889599 on ClinicalTrials.gov