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 Study Participants 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 Study Participants 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 Study participants will be excluded if they have any signs of renal or liver impairment and also if exhibits above the normal range 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 of study period and until the completion of the study Consumption of alcohol and its products and poppy containing foods within 48.00 hours prior to clinic admission and until the completion of the study Study 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 strong CYP2C8 inhibitors strong CYP3A4 inducers CYP3A4 substrates CYP2C9 substrates or CYP2C19 substrates at any time within 14 days prior to dosing and any vaccine including COVID 19 vaccine from 14 days prior to check in and throughout the study Study Participants who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and until the completion of the study study participant who had participated in any other study within the 90 days of check in Any history or presence of asthma including aspirin induced asthma or nasal polyp or NSAIDs induced urticaria 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 study period or history of drug addiction Positive results for alcohol test prior to check in of study 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 A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies A positive test result for HIV antibody 1 & or 2 Consumption of grape fruit or grape fruit products within 72.00 hours prior to dosing Use of hormone replacement therapy for a period of 06 months prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Oral dose Bioequivalence of Enzalutamide 160 mg/5ml 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 4 40mg Tablets Marketing Authourisation Holder Astellas Pharma Europe B V Sylviusweg 622333 BE Leiden The Netherlands and supportive comparator XTANDI Enzalutamide 160 mg soft gelatin capsules 4 40mg Manufactured by Catalent Pharma Solutions LLC for Astellas Pharma US Inc Northbrook IL 60062 in healthy adult human male study participants under fasting conditionsTimepoint: 32 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 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.17 Hrs 02.33 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 12.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 96.00 Hrs 144.00 Hrs 192.00 Hrs 240.00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male study participants under fasting conditionsTimepoint: 32 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 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.17 Hrs 02.33 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 12.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 96.00 Hrs 144.00 Hrs 192.00 Hrs 240.00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed