A bio-equivalence study to characterize the rate and extent of absorption of Melphalan after oraladministration and to assess the bioequivalence of the sponsorâ??s test productMelphalan Tablets 2 mg relative to that of the reference product ALKERAN®(melphalan) Tablets 2 mg in adult patients
- Conditions
- Health Condition 1: null- Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated.
- Registration Number
- CTRI/2013/12/004205
- Lead Sponsor
- Alvogen Pine Brook Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the rate and extent of absorption of Melphalan after oral <br/ ><br>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 Outcome Measures
Name Time Method To investigate the safety and tolerability of both the formulations.Timepoint: basis of clinical and laboratory examination, documentation of the Adverse Events