None listed
Conditions
Interventions
Intervention1: Enzalutamide 80 mg Tablet: Enzalutamide 80 mg Tablet will be administered as single dose in each period total duration is 19 Days
Control Intervention1: XTANDI Enzalutamide 80 mg Table
Sponsors
BDR pharmaceuticals Internationals Pvt Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human male subjects of age above 18 to 45 years and Body Mass Index BMI ranges between 18 50 kg/ per m2 to 29 99 kg per m2 Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous systems and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram (ECG) Chest X-Ray and clinical laboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Subjects willing to use adequate contraception during sexual intercourse with female partners of child bearing potential during the study and for a period of 03 months after receiving last dose of Enzalutamide
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Enzalutamide or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant on going chronic medical illness Renal or liver impairment History of or risk factors for seizure Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes tobacco containing products for at least 48 00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study Subjects who have taken an unusual diet for whatever reason e g low salt for 48 00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 180 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of check-in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc Canada Packed by Astellas Pharma Europe Holanda Imported by Astellas Farma Brasil Sao Paulo In Healthy Adult Human Male Subjects Under Fasting ConditionsTimepoint: 26 samples 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs 72 00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of healthy adult human male subjects under Fasting conditionsTimepoint: 26 samples 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs 72 00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed