| CTRI Number |
CTRI/2025/10/095860 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Single Dose Two Treatment Partial Replicate Oral Bioequivalence Study Comparing Elacestrant 345 mg Tablet with ORSERDU Elacestrant 345 mg film coated tablet In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Truncated Partial Replicate, Reference scaled Average Oral Bioequivalence Study Comparing Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SLS-BE-0012-25-ELAC Version: 02 Date: 16 Jul 25 |
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 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 Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 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 Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 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 International Pvt.Ltd
Engineering Centre, 6th floor,
9, Matthew Road,
Opera House, Mumbai 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 |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore641029 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 Lifescience andResearch privatelimited |
Clinical Pharmacology unit GroundFloor No 29 A Krishna MaduravanamVellakinar pirivu ThudiyalurCoimbatore 641029
Coimbatore
TAMIL NADU
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research EthicsCommittee RegistrationNoECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt.Ltd, India |
A Single oral dose of Elacestrant 345 mg Tablet will be administered ineach period Total Duration is 41 days |
| Comparator Agent |
ORSERDU (Elacestrant) 345 mg film-coated tablet Manufactured by Stemline Therapeutics B.V. Basisweg 10 1043 AP Amsterdam The Netherlands |
A Single oral dose of ORSERDU Elacestrant 345 mg film-coated tablet will be administered ineach period Total Duration is 41 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy Human Male and Post Menopausal Female subjects of age between 18-60 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 (according to the formula BMI = weight (kg) height (m)2
Female Subjects should have at least 12 month of amenorrhea
Postmenopausal status confirmed by
Screening Estradiol
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 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 non vegetarian diet
Willing to comply with all requirements of this study protocol as well as instruction from the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination (for female subjects period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check-in for each period
Subjects should have protected sexual contact including dose interruptions by using a latex or synthetic condom every time they have sexual intercourse with a female of reproductive potential during study and for 02 weeks after receiving their last dose of Elacestrant even if they have undergone a successful vasectomy
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Elacestrant 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
cigarettes and 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 any unusual diet, for whatever reason e.g. 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
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 this study 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
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females who are are likely to become pregnant during the course of the study
|
|
|
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 on Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions |
28 Time Points
00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 33 hrs 01 67 hrs 0 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 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 test product comparing with the reference product in healthy Human Male and Post Menopausal Female subjects under fed conditions |
28 Time Points
00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 33 hrs 01 67 hrs 0 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 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="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
16/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
At least 42 number of healthy, Human Male and Post
Menopausal Female 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 42 subjects in period I alone.
Note: If needed the study will be conducted as batch wise
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 18 days will be maintained between each dosing period
In each period, after an overnight fasting of at least 10.00
hours prior to high-fat, high-calorie non veg breakfast. In the morning
high-fat, high-calorie non veg breakfast will be provided 30 minutes before
dosing. 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) with 240 mL of drinking water
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 03.00, 06.00, 12.00, 24.00, and 48.00
hours (± 60 minutes) post-dose
Monitoring for adverse events will be done throughout the
study period in clinical phase
|