None listed
Conditions
Sponsors
BDR pharmaceuticals International Pvt Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human male subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 30.00 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 or 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 system 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 ongoing chronic medical illness Renal or liver impairment 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 for at least 48.00 hours prior to check-in of each period and until completion of the study Consumption of cigarettes and tobacco containing products for at least 6 months prior to check-in of each period and until completion of the study Consumption of alcohol and its products and poppy containing foods within 48.00 hours prior to clinic admission and until completion of the study within 72.00 hours prior to clinic admission and until completion of the study Trial participants 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 and enzyme modifying medications within 30 days prior to study check-in and throughout the study Trial participants who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and until completion of the 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 any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins History of or risk factors for seizure 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 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India With XTANDI® Enzalutamide 160 mg 80 mgx2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 in Healthy adult human male subjects Under Fed ConditionsTimepoint: 29 Time points 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 06 50 hrs 07 00 hrs 07 50 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male subjects under fed conditionsTimepoint: 29 Time points 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 06 50 hrs 07 00 hrs 07 50 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed