A bio-equivalence study to characterize the rate and extent of absorption of Vinorelbine after oral administration of the sponsorâ??s test product Vinorelbine soft capsule 60 mg/m2 relative to that of the reference product 60 mg/m2 of NAVELBINE® soft capsule in adult patients.
- Conditions
- Health Condition 1: null- Patients with advanced breast cancer
- Registration Number
- CTRI/2016/04/006892
- Lead Sponsor
- otus Pharmaceutical Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
1.Previously treated advanced breast cancer patient failed on standard treatment of anthracyclins and taxanes.
2.Patients aged 18 and 65 years (both inclusive).
3.Patients with ECOG performance status <= 2 and life expectancy of at least 6 months as judged by the investigator.
4.Patients who have minimum interval of our-weeks between the end of previous chemotherapy and study entry.
5. Patients who agree to participate in the study and give their informed consent.
6. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.
1. Patients on previous vinorelbine treatment
2. Patients on treatment with oral anticoagulants
3. Patients on treatment with enzyme inducers ( such as ketoconazole and erythromycin) / enzyme inhibitors( such as rifampicin and barbiturates)
4. Patients with any pre-existing major medical condition.
5. Patient with current or prior history of evidence of central nervous system metastasis.
6. Patients with extensive pulmonary and hepatic metastasis.
7. Patients with pre-existing clinically significant peripheral neuropathy;
malabsorption syndrome or disease affecting the gastrointestinal tract function.
8. Patients with previous surgical resection of stomach or small bowel.
9. Patients with any psychological, family, sociological or geographical conditions hampering medical follow-up or compliance with the study
protocol.
10.Patients with history of current or previous use of any recreational drugs or history of drug addiction.
11.Patients with history of smoking and alcoholism
12.Difficulty in swallowing capsules/tablets
13.Patients with severe vomiting.
14.Patients who are positive for HIV, VDRL/RPR, Hepatitis B & C tests.
15.Pregnant or lactating women.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method