None listed
Conditions
Interventions
Intervention1: Enzalutamide Capsules 80 mg: a single oral dose of one Capsule of Test Product
Enzalutamide Capsules 80 mg manufactured by Hetero Healthcare Ltd OR one Capsule Reference Product (R) BDE
Sponsors
Hetero Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to give Informed Consent. 2. Healthy adult male subjects within 18-45 years of age (both inclusive). 3. Body Mass Index (BMI) having range between 18.5 and 30.0 kg/m2 (both inclusive). 4. Willingness to follow protocol requirements as per the subject information sheet. 5. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. 6. Subjects whose screening laboratory values are within normal limits or considered by the Physician / Principal Investigator / Co-Investigator to be of no clinical significance. 7. Physical examination and vital sign examination of the subject conducted on the day of screening and check-in are within acceptable limits. 8. Subjects who agree to abstain from consuming any xanthine / caffeine containing food or beverages (chocolates, tea, coffee or cola drinks), grapefruit juice and products, alcoholic products, cigarettes and tobacco products for at least 48.00 hours prior to dosing and throughout the study period until the last blood sample is being obtained. 9. Volunteers willing to use most effective barrier contraceptive methods during and for three months after the end of treatment. In addition, volunteers will be instructed not to have sexual intercourse with pregnant woman.
Exclusion criteria
Exclusion criteria: 1. History of allergy or hypersensitivity or intolerance to Enzalutamide or related class of drugs or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study; 2. Significant medical disorder (cardiovascular, gastrointestinal, renal, pulmonary, haematological, endocrine, or metabolic disorder (e.g. diabetes mellitus), malignancy, or immunodeficiency disorder, hepatic and neurological or psychiatric) as determined by history. 3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, bloodâ??forming organs etc. 4. Significant abnormal finding as determined by clinical examination including 12-lead ECG and vital signs. 5. Any major illness or hospitalized within 90 days prior to the first check-in; Use of any recreational drug or history of drug addiction. 6. History of difficulty in accessibility of veins in arms and difficulty in withdrawing the blood. 7. Difficulty in swallowing the oral medication. 8. Found positive in alcohol consumption test done before check-in and ambulatory samples for single study period. 9. Found positive in urine test for drugs of abuse done before check-in. 10. Depot injections or implants within 6 months. 11. Positive screening test for any one: HIV, hepatitis B, hepatitis C and VDRL. 12. Consumption of xanthine / caffeine containing products, tobacco containing products, grapefruit juice and products and alcohol within 48.00 hours prior to dosing. 13. Refusal to abstain from food for at least 10.00 hours prior to study drug administration and until at least 04.00 hours post-dose. 14. Refusal to abstain from consumption of tobacco products 48.00 hours prior to dosing until the last blood sample collection of last study period. 15. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration until at least 01.00 hour post-dose except 240 ± 02 mL of drinking water. 16. Requirement of any medication for chronic illness including Hormonal Replacement Therapy and enzyme modifiers. 17. Consumption of any prescribed medication (including herbal medicines and vitamin supplements) or OTC drugs during 21 days prior to dosing and till the end of the study. 18. Subject has a history of allergic response to foods, which are being used in the study meal. 19. Participation in any clinical study during 90 days prior to administration of study medication. 20. Blood donation during 90 days prior to administration of study medication. 21. Clinically significant illness within 4 weeks before start of study. 22. Criteria for blood pressure and pulse: - Systolic blood pressure below 110 mm of Hg or above 140 mm of Hg. - Diastolic blood pressure below 70 mm of Hg or above 90 mm of Hg. - Minor deviation (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician / investigator. - Pulse rate below 70/ minute or above 100/ minute. 23. Subjects with any condition, which in the opinion of the investigators makes the subject unsuitable for inclusion. 24. Volunteers not willing to use most effective barrier contraceptive methods during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-72Timepoint: at pre-dose (within 00.50 hour prior to dosing) and at 00.167, 00.33, 00.50, 00.67, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| TmaxTimepoint: at pre-dose (within 00.50 hour prior to dosing) and at 00.167, 00.33, 00.50, 00.67, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose | — |
Countries
India
Contacts
Public ContactMr P Narender reddy
Bio Scientific Research Laboratories (I) Pvt. Ltd.
Outcome results
None listed