| CTRI Number |
CTRI/2026/03/106959 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Single Dose Two Period TTruncated Oral Bioequivalence Study Comparing Enzalutamide 160 mg Tablets With Xtandi Enzalutamide 160 mg Tablets In Healthy Adult Human Male Subjects Under Fed Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Cross Over Truncated Oral Bioequivalence Study Comparing Enzalutamide 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Xtandi® Enzalutamide 160 mg 80 mg ×2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 In Healthy Adult Human Male Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SLS-BE-0108-24-ENZA Version No: 06 Date: 11 Mar 26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinarpirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinarpirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinarpirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| BDR pharmaceuticals International Pvt Ltd Engineering Centre 6th floor 9 Matthew Road Opera HouseMumbai 400004 India |
|
|
Primary Sponsor
|
| Name |
BDR pharmaceuticals International Pvt Ltd |
| Address |
Engineering Centre 6th floor 9 Matthew Road Opera House Mumbai 400004 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
Door No 29 A Krishna Madura Vanam
Alankar Thottam Vellakinar Pirivu
Thudiyalur Coimbatore Tamil Nadu 641029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Life science and Research private limited |
Spinos Lifescience and Research private limited
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed Condition |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Enzalutamide 160 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India |
A Single oral dose of Enzalutamide 160 mg Tablets will be administered in each period Total Duration is 50 Days |
| Comparator Agent |
XTANDI® Enzalutamide 160 mg 80 mgx2 Tablets Distributed by Astellas Pharma US Inc Northbrook IL 60062 |
A Single oral dose of Enzalutamide 160 mg 80mgx2 Tablets will be administered in eachperiod Total Duration is 50 Days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 Conditions |
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 Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male subjects under fed conditions |
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 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
At least 64 number of healthy, adult, human male subjects will be recruited to evaluate the bioequivalence of Test product with the Reference product. As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 64 subjects in period I alone. Note: If needed the study will be conducted as batch wise.Demographic data, medical and medication history, physical examination, 12 lead ECG, hematology, biochemistry, serology, urine routine analysis will be done within 21 days and a chest X-ray within 06 months prior to check-in. In each period, subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 30 days will be maintained between each dosing period. Subjects will be served dinner on the day of check-in for each period. Thereafter, subjects will fast for at least 10.00 hours prior to high fat, high calorie non veg breakfast. High-fat, high-calorie non veg breakfast will be provided 30 minutes before dosing. Standard meals will be provided at 04.00, 08.00, 12.00, 24.00, 28.00, 32.00, 36.00, 48.00, 52.00, 56.00 and 60.00 hours post-dose respectively. All meal plans will be identical in all the periods of the study. The subjects will fast for at least 10.00 hours prior to high-fat, high-calorie non veg breakfast and 04.00 hours post-dose Blood pressure, radial pulse rate, body temperature, and wellbeing status will be enquired and recorded at pre-dose 00.00 hour (within 75 minutes of before dosing) and at 01.00, 02.00, 04.00, 06.00, 08.00, 12.00, 24.00 and 48.00 hours (± 60 minutes) post dose Physical examination and vitals will be recorded before check-in, check-out (72.00 hours) for each period and at any time if necessary. ECG will be recorded before check out (72.00 hours) for each period and if any subject is withdrawn or dropped out during the study. Monitoring for adverse events will be done throughout the study period in clinical phase. |