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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.

An open label, randomized, balanced, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study of 60 mg/m2 of Vinorelbine soft capsule from Lotus Pharmaceutical Co., Ltd., Taiwan compared with that of 60 mg/m2 of NAVELBINE® soft capsule marketed by PIERRE FABRE Limited, Winchester Hampshire S023 7DR, United Kingdom, in adult, patients with advanced breast cancer under fed conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/04/006892
Enrollment
66
Registered
2016-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with advanced breast cancer

Interventions

Intervention1: Vinorelbine 30 mg soft capsules: Single dose of 60 mg/m2 of the Vinorelbine 30 mg soft capsules will be given to the subjects as part of their chemo regimen. Control Intervention1: NAVE

Sponsors

Lotus Pharmaceutical Co Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To characterize the rate and extent of Vinorelbine absorption after oral administration and to assess the bioequivalenceTimepoint: To assess the bioequivalence, blood sample collection will be performed at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 12.00, 24.00, 48.00 and 72.00 hours after administration of study drug.—

Secondary

MeasureTime frame
To assess and tabulate the adverse events and any other safety concerns during the study, and tolerability of both the formulations.Timepoint: on the basis of clinical and laboratory examinations, documentation of the Adverse Events.—

Countries

India

Contacts

Public ContactDrRajeev Siddaraj

Norwich Clinical Services Pvt. Ltd.

rajeev.siddaraj@norwichclinical.com09448088817

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026