Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Test Product: Abiraterone acetate and Niraparib Tablets 500 mg/100 mg
Manufactured by: Sandoz Private Limited, India: Two tablets of Abiraterone acetate and Niraparib Tablets 500 mg/10
Sponsors
Lek Pharmaceuticals d.d Slovenia on behalf of Sandoz Private Limited, India
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male patients more than 18 years of age and having BMI in the range of 18.5 to 28 kg per m2 (both inclusive) 2. Patients who are willing to provide an archived tumor sample for determination of homologous recombination repair (HRR) gene alteration status, if not performed in the past or its documented evidence of gene alteration status. 3. Patients that are non-smokers and ex-smoker (an ex-smoker is defined as someone who has completely stopped using nicotine products for at least 90 days prior to study drug administration). 4. Patients that provide written informed consent for participation in the study. 5. Patients that are already on a stable dose of FDC of Niraparib and Abiraterone for at least 12 days 6. Able to take oral medication without crushing, dissolving, or chewing tablets. 7. Patients must have a life expectancy of more than 3 months. 8. Patients may have received prior radiation therapy or surgery. However, at least 28 days must have elapsed since completion of radiation therapy or surgery and patient must have recovered from all side effects at the time of screening 9. Patients who are willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). 2. Symptomatic brain metastasis or ascites (Annexure II) or pleural effusion. 3. Blood loss (1 unit or 350 ml) within 90 days prior to first dosing in Period I for the current study. 4. Known active hepatitis B virus (eg, hepatitis B surface antigen reactive) or active hepatitis C virus (HCV; eg, HCV ribonucleic acid [RNA] [qualitative] is detected). 5. Human immunodeficiency virus positive patients. 6. Severe bone injury caused by tumor bone metastases as judged by the Investigator, including severe bone pain due to poor control, pathological fracture of important parts or spinal cord compression occurred in the last 6 months or expected to occur in the near future. 7. Patients with uncontrolled diabetes mellitus (HbA1c greater then 9%) and hypertension as per investigators discretion 8. Patients positive on Breath alcohol analyzer test at the time of baseline or randomization visit. 9. Positive on urine test for drugs of abuse prior to receiving the first dose of investigational medicinal product in the study. 10. Difficulty in swallowing tablets. 11. Problems with fasting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the bioequivalence between two tablets of FDC of Niraparib 100 mg and Abiraterone Acetate 500 mg of Sandoz (test formulation) once daily and two tablets of Akeega1 (FDC of Niraparib 100 mg and Abiraterone Acetate 500 mg, once daily) of Janssen Biotech, Inc., USA (reference product) in patients with mCRPC (metastatic Castration-Resistant Prostate Cancer) with BRCA1/2 mutation (germline and/or somatic) under fasting conditionsTimepoint: Pre dose PK blood sample on day 01,07,08,09,17,18 and 19. Post dose PK blood sample on Day 09,10,19,20. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of the test product compared to reference product by monitoring adverse eventsTimepoint: To monitor the adverse events of patients and to assess safety of each of the two formulation up to day 28. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Limited
Outcome results
None listed