| CTRI Number |
CTRI/2025/06/089848 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| 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 Two Treatment Three Sequence Three Period Partial Replicate Reference scaled Average Oral Bioequivalence Design In Healthy Adult Human Subjects Under Fasting Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Partial Replicate Reference scaled Average Oral Bioequivalence Study Comparing Resmetirom 100 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India with Rezdiffra Resmetirom 100 mg Tablets Manufactured and Distributed by Madrigal Pharmaceuticals West Conshohocken PA In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0013-25-RESM Version No: 01 Date:11 Feb 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 pirivuThudiyalur 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 pirivuThudiyalur 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 pirivuThudiyalur 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 ResearchPrivate limited |
M s SpinoS Lifescience And Research
Private Limited
Door No 29A Krishna Maduravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore 641029
Tamil Nadu |
|
|
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 |
Spinos Lifescience andResearch privatelimited
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resmetirom 100 mg Tablets Manufactured by BDR Pharmaceuticals International Pvt Ltd India |
A Single oral dose of Resmetirom 100 mg Tablets will be administered ineach period Total Duration 14 Days |
| Comparator Agent |
Rezdiffra Resmetirom 100 mg Tablets Manufactured and Distributed by Madrigal Pharmaceuticals West Conshohocken PA |
A Single oral dose of Rezdiffra Resmetirom 100 mg Tablets will be administered in each period Total Duration is 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human male and female subjects of age between 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 physicianor 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 nervoussystem 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 instruction from the study personnel
Non smokers
Generally healthy, as documented by gynaecological examination and breast examination period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period
If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
non-childbearing potential defined as
greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of childbearing potential willing to commit to using a consistent and acceptable method of birth controlas defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Resmetirom 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 i e 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 or 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 Resmetirom 100 mg Tablets Manufactured by BDR Pharmaceuticals International PvtLtd India with Rezdiffra Resmetirom 100 mg Tablets Manufactured & Distributed by Madrigal Pharmaceuticals, West Conshohocken PA, In Healthy Adult Human Subjects Under Fasting Conditions |
21 blood samples
00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 03 00 hrs 03 25 hrs 03 50 hrs 03 75 hrs 04 00hrs 04 25 hrs 04 50 hrs
04 75hrs 05 00 hrs 05 50 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a single dose test and reference products administered in Healthy Adult Human Subjects Under Fasting Conditions |
21 blood samples
00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 03 00 hrs 03 25 hrs 03 50 hrs 03 75 hrs 04 00hrs 04 25 hrs 04 50 hrs
04 75hrs 05 00 hrs 05 50 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
24/09/2025 |
| 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 48 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 48 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 48.00 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 Ovo
lacto-vegetarian diet, 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 |