Health Condition 1: null- Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated.
Conditions
Interventions
Intervention1: ALKERAN® (melphalan) Tablets 2 mg: After a supervised overnight fast, patients will receive a single oral dose of the assigned reference product ALKERAN® (Melphalan Tablets 2 mg) with
Sponsors
Alvogen Pine Brook Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated. 2. Patients aged 18 years or above. 3. Patients who did not receive the last dose of melphalan or nonmelphalan chemotherapy in the last 4 weeks prior to the first dose of the study medication. 4. Patients agree to participate in the study and give their written informed consent. 5. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit. 6. Patients with ECOG (Eastern Cooperative Oncology Group)performance status score of 0-2.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug. 2. Patients who received mitomycin C within 8 weeks prior to the first dose of the study. 3. Patients who had a significant surgery within 2 weeks prior to enrolling in study and as per the investigator, their inclusion may affect the objective of the study. 4. Patients having metastatic disease involving the central nervous system. 5. Patients who are scheduled to receive radiotherapy during the study period. 6. Patients with leukocyte count below 3,000 cells/mcL or the platelet count below 100,000 cells/mcL. 7. Previous enrollment in this study or participating in any other study in the past 30 days. 8. Any uncontrolled medical problem, e.g. heart, lung disease or clinically significant abnormal laboratory values that in the opinion of the investigator and/or sponsor would preclude safe administration of the study drug. 9. Patients with history or presence of renal insufficiency and and azotemia. 10. History or presence gastrointestinal ulceration, bleeding and/or perforation. 11. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis 12. Difficulty in swallowing tablets. 13. Positive urine drug screening, alcohol breath analysis, HIV, VDRL/RPR, Hepatitis B & C tests. 14. Female patients demonstrating a positive pregnancy screen or currently breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the rate and extent of absorption of Melphalan after oral administration and to assess the bioequivalenceTimepoint: The pre-dose (0.00 hour) blood sample (each 4 mL) will be collected within 1 hour prior to dosing. The post-dose blood samples (each 4 mL) will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 5.00, 6.00 and 8.00 hours after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of both the formulations.Timepoint: basis of clinical and laboratory examination, documentation of the Adverse Events | — |
Countries
India
Contacts
Public ContactDr Rajeev Siddaraj
Norwich Clinical Services Pvt. Ltd.
Outcome results
None listed