Health Condition 1: null- Prostate cancer patients
Conditions
Interventions
Intervention1: Nilutamide 150 Mg tablets: Oral administration under fasting condition, multiple dose.OD dose of 150 mg tablet of Nilutamide (Test/Reference) will be given for (4 weeks during stabiliza
Sponsors
EirGen Pharma Ltd
Reliance Life Sciences PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Adult patients suffering from prostate cancer; aged between 18 to 70 years. 2. Patients with histologically confirmed prostate cancer not amenable to curative therapy with surgery or radiation, and had evidence of progressive disease despite treatment with adequate hormonal therapy, as defined by continued treatment with an LHRH agonist or previous orchidectomy, and after treatment with either/or both flutamide or bicalutamide 3. Patients willing to voluntarily provide written informed consent. 4. Patients willing to undergo pre and post-study physical examinations and laboratory investigations. 5. Eastern Cooperative Oncology Group performance status of 0â??2 6. Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in-house monitoring and the remaining based on history) and during their clinical stay in each study period. 7. Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and should agree not to take any amount of alcohol during the study period. 8. Patients able and willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Patients incapable of understanding the informed consent process. 2. Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study 3. Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements. 4. Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results. 5. Any treatment which could affect the pharmacokinetic of Nilutamide/known interactions 6. Patients with a known history of drug hypersensitivity to nilutamide or any excipients of the formulation. 7. Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates). 8. Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive. 9. Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit 10. Patients who, have clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), c-glutamyltranspeptidase, serum bilirubin, serum glucose (fasting) etc. 11. Patients with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive). 12. Patients with a clinically significant past history or current medical condition of: • Pulmonary disorders (COPD and asthma) • Cardiovascular disorders (especially cardiac blocks) • Neurological disorders (especially seizures, migraine) • Renal and/or hepatic disorders • Visual abnormality 13. Patients who have participated in any other clinical investigation or have bled more than 300 ml in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence of the two formulations (T vs R) in relation to the: Rate of absorption Extent of absorption Timepoint: Bioequivalence of the two formulations (T vs R) in relation to the: Rate of absorption Extent of absorption | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor all the adverse events, including laboratory parameters Timepoint: Assessment of thepharmacokinetic parameters | — |
Countries
India
Contacts
Public ContactDr Sanjeev Hegde
Reiance Life Sciences Pvt.Ltd
Outcome results
None listed