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 The list of approved contraceptive methods include Condom with spermicide latex or synthetic Vasectomy if confirmed as successful Sexual abstinence if this is the subjects consistent and preferred lifestyle choice Female partner using highly effective contraceptive methods such as Intrauterine device IUD Hormonal contraception eg oral contraceptive pill implant injection Tubal ligation
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 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 Subjects with a history of seizures or any condition that may predispose them to seizures eg prior cortical stroke significant brain trauma or concurrent use of medications known to lower seizure threshold Subjects will be excluded if they have any signs of renal or liver impairment and also if exhibits above the normal range RENAL PARAMETERS Serum Urea Upto 50.4 mg/ dL Serum Creatinine Upto 1.54 mg/ dL Creatinine clearance lesser than 60 mL/min LIVER FUNCTION PARAMETERS Total bilirubin Up to 1.82 mg/ dL Alanine Transaminase ALT Not more than 90 U/ L Aspartate Transaminase AST Not more than 70 U/ L Alkaline Phosphatase ALP Up to 162 U/ L Albumin 3.06- 5.72 gm/ dL Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and 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 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 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 Bioavailability of Enzalutamide 160 mg/5 mL oral solution Manufactured by QUAGEN PHARMACEUTICALS LLC 34 Fairfield Place West Caldwell New Jersey NJ 07006 United States for BDR Pharmaceuticals International Pvt Ltd India With XTANDI Enzalutamide 160 mg 40mg 4 soft Capsules Manufactured by Catalent Pharma Solutions LLC for Astellas Pharma US Inc Northbrook IL 60062 in Healthy adult human male subjects Under Fasting ConditionsTimepoint: 29 Time points 00.00 Hrs 00.08 Hrs 00.17 Hrs 00.25 Hrs 00.33 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.17 Hrs 01.33 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.25 Hrs 02.50 Hrs 02.75 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 24.00 Hrs 48.00 Hrs 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 fasting conditionsTimepoint: 29 Time points 00.00 Hrs 00.08 Hrs 00.17 Hrs 00.25 Hrs 00.33 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.17 Hrs 01.33 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.25 Hrs 02.50 Hrs 02.75 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 24.00 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