| CTRI Number |
CTRI/2024/10/075376 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Balanced Randomized Single Dose Cross Over Truncated Oral Bioequivalence Study Comparing Enzalutamide 80 Mg Tablets |
Scientific Title of Study
Modification(s)
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Cross Over Truncated Oral Bioequivalence Study Comparing Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc 2100 Syntex Court Mississauga Ontario Canada Packed by Astellas Pharma Europe B V Hogematt 2 7942 JG Meppel Holanda Imported by Astellas Farma Brasil Importacao E Distribuicao de Medicamentos Ltda Avenida Guido Caloi 1 935 Bloco B 2 Andar Sao Paulo SP CNPJ 07 768 134 0001 04 In Healthy Adult Human Male Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0014-24-ENZA version 01 dated 01 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu 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 Life science and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu 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 Life science and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| BDR pharmaceuticals Internationals Pvt Ltd
Engineering Centre 6th floor 9 Matthew Road Opera House Mumbai Maharashtra India 400004 |
|
|
Primary Sponsor
|
| Name |
BDR pharmaceuticals Internationals Pvt Ltd |
| Address |
Engineering Centre 6th floor
9 Matthew Roa
Opera House
Mumbai 400004
India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore 641029
Tamil Nadu
India
|
|
|
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 |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed Conditions |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Enzalutamide 80 mg Tablet |
single oral dose of Enzalutamide 80 mg Tablet will be administered in each period Total Duration is 19 Days |
| Comparator Agent |
XTANDI Enzalutamide 80 mg Tablets |
single oral dose of XTANDI Enzalutamide 80 mg Tablet will be administered in each period Total Duration is 19 Days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Normal healthy adult human male subjects of age above 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 29.99 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/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 systems and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume non 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 on going chronic medical illness
Renal or liver impairment
History of or risk factors for seizure
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 cigarettes 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 an 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 180 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the bioequivalence of Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc Canada Packed by Astellas Pharma Europe Holanda Imported by Astellas Farma Brasil Sao Paulo In Healthy Adult Human Male Subjects Under Fed Conditions |
26 samples
00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 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 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs and 72 00 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of healthy adult human male subjects under Fed conditions |
26 samples
00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 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 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs and 72 00 hrs
|
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
30/10/2024 |
| 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) |
Not Yet Recruiting |
|
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)
|
Enough volunteer shall be recruited in order to evaluate and start the study with at least 18 subjects, as this bioequivalence study will be conducted on healthy, adult, human male subjects. As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 18 subjects in period IIn Each period, subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose, with a washout period of at least 14 days from the successive dosing day. Note: latex or synthetic condom will be provided at each period of check out. After consumption of breakfast, in the morning a single oral dose of, either the test product (T) or reference product (R) will be administered as per the randomization schedule Physical examination, 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 or after any subject is withdrawn or dropped out from the study.
|