A bioequivalence study of Enzalutamide enzalutamide capsule 80 mg in healthy adult male subjects under fastingconditions.
- Registration Number
- CTRI/2023/03/051091
- Lead Sponsor
- Hetero Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method