Health Condition 1: C929- Myeloid leukemia, unspecified
Conditions
Interventions
Intervention1: Azacitidine tablet 300 mg: Dose Formulation: Tablet,Unit
Dose Strength(s):300 mg
Dosage Level(s) 1 tablet of 300 mg orally in each period.
Route of Administration: Oral
Duration of Dos
Sponsors
Veeda Clinical Research Limited
MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Key Inclusion 1. Male or non-pregnant, non-lactating female patients 18 to 64 years (both inclusive) of age. 2. Able to give written informed consent for participation in the trial 3 Patients with documented diagnosis of Acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy with or without consolidation therapy. 4. Patients that are to be initiated on consolidation therapy with Azacitidine 300 mg tablet or patients who are already on a stable dose of Azacitidine 300 mg tablet (for these patients a washout of 14 days of their ongoing Azacitidine 300 mg tablet must be ensured prior to randomization in the study). 5. Patients with a history of treated brain metastases should be clinically stable for more than or equal to 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system edema is permitted if the dose is less than or equal to 20 mg of prednisolone or equivalent. 6. Patients who are not eligible for or choose not to proceed to, hematopoietic stem cell transplantation (HSCT). 7. Patients having an estimated survival of at least 3 months. 8. Adequate organ and bone marrow function based upon the following laboratory criteria, a) Hemoglobin =8.0 g/dL b) Absolute neutrophil count =1000/uL c) Platelet count =75,000/uL Creatinine Clearance = 30 mL/min (calculated based on Cockcroft-Gault formula) Total Bilirubin ? 1.5 times ULN SGOT (AST) ? 2.5 times ULN SGPT (ALT) ? 2.5 times ULN 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 10. 12-lead ECG with no clinically significant findings at screening. As determined by the Investigator. 11. Women of child bearing potential, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must have negative pregnancy test at screening visit and before randomization; and must agree to use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 6 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. 12. In case of Male patients: The patient and his partner must agree to use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 3 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician
Exclusion criteria
Exclusion criteria: Key Exclusion 1. History of known hypersensitivity to azacitidine or its components which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study. 2. Patients found positive for HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening. 3. Have ongoing clinically significant adverse event(s) due to prior treatments administered, as determined by the investigator. 4. Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product administration. 5. History of inflammatory bowel disease e.g. Crohns disease, ulcerative colitis, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and or predispose the patient to an increased risk of gastrointestinal toxicity. 6. Patients treated with proton pump inhibitors like Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole and Rabeprazole within 4 weeks prior to start of IMP or require as concomitant medication. 7. In the opinion of the Investigator, the patient will not be compliant with the requirements of the study procedures. 8. Participation in another drug research study within 90 Days or 5 half lives, whichever is longer prior to receiving the first dose of investigational medicinal product for the current study. 9. History of difficulty in accessibility of veins. 10. Patient positive on Breath alcohol analyzer test at the time of baseline visit (Check in Day 0). 11. Positive for drugs of abuse prior to receiving the first dose of investigational medicinal product in the study. 12. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the patient in case of participation in the study. 13.Patients with psychiatric illness or social situations that would limit compliance with study requirements. 14. Patients with any uncontrolled medical condition e.g.cardiovascular disease, hypertension, diabetes mellitus etc. or active infection, etc or any abnormal laboratory findings, which, in the Investigators opinion, would contraindicate, or interfere with absorption of the study drug or jeopardize the safety of the patient. 15. Patients with impaired ability to swallow oral medication. 16. Patients with uncontrolled systemic fungal, bacterial, or viral infection patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics & establish bioequivalence of the sponsor’s Test Product (Azacitidine 300 mg film-coated tablet) relative to that of Reference Product ONUREG (Azacitidine) 300 mg film-coated tablet in adult acute myeloid leukemia.Timepoint: Day 1 - Period I, Day 2- Period II, Day 3 - Period III and Day 4 - Period IV: (full replicate BE study, each period is for 1 day) | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the patients.Timepoint: Day 1 , day 2 , day 3, Day 4. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Limited
Outcome results
None listed