| CTRI Number |
CTRI/2024/07/070478 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To study the bioequivalence of Relugolix 120 mg tablets |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0024-24-RELU Version 02 Date 18 Apr 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd |
| Address |
Clinical Department
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd |
| Address |
Clinical Department
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd |
| Address |
Clinical Department
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| BDR Pharmaceuticals Internationals Pvt Ltd
Opera house Mumbai - 400004 |
|
|
Primary Sponsor
|
| Name |
BDR Pharmaceuticals Internationals Pvt Ltd |
| Address |
Engineering Centre 6th Floor
9 Mathew Road Opera house Mumbai 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
No 29 A Krishna Maduravanam velakinar Pirivu Thudiyalur Coimbatore 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 |
Spinos Lifescience and Research Pvt Ltd |
Clinical Department
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU |
8220586899
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Orgovyx 120 mg tablet |
120 mg tablet
Oral Dose
Four Times |
| Intervention |
Relugolix 120 mg Tablet |
120 mg tablet
Oral Dose
Four Times |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/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 or
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 may not be limited to an evaluation of the cardiovascular gastrointestinal
respiratory musculoskeletal and central nervous system) and vital sign
assessments
Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X Ray
and clinical laboratory assessments
Willing to consume Ovo lacto-vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
If male and sexually active the subject is willing to commit to 2 acceptable
methods of birth control for the duration of the study up to 14 days from the last dose |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Relugolix or its inactive ingredients
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Consumption of caffeine and or Xanthine containing products cigarettes and tobacco
containing products for at least 48.00 hours prior to check-in |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Relugolix 120 mg Tablets |
22 blood samples
00.00, 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 48.00, and 72.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome TimePoints
To assess the safety and tolerability of Relugolix 120 mg tablets |
22 blood samples
00.00, 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 48.00, and 72.00 hours |
|
|
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)
|
01/07/2025 |
| Date of Study Completion (India) |
16/10/2024 |
| 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)
Modification(s)
|
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
|
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two Sequence, Crossover, Truncated, Four-Period, Fully Replicate, Reference Scaled Average Oral Bioequivalence Study Design. Enough volunteers shall be recruited in order to evaluate and start the study with at least 48 subjects, as this Bioequivalence study will be conducted on healthy, adult, human male subjects. 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 and the washout period of at least 21 days from the successive dosing day.
After collection of blood samples from all the subjects at each time point, study personnel will place the collected samples in a thermo-insulated box containing wet ice and transfer the box to the sample processing room where the blood samples will be centrifuged at 4000 ± 50 RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will start within 30 minutes of the collection of samples, at each collection time-point. The resulting plasma will be equally transferred to pre-labeled polypropylene tubes into two aliquots. The plasma samples will be then stored in a freezer at the temperature of -30 ± 10°C or -70 ± 15°C at the clinical site and bio-analytical sites. |