| CTRI Number |
CTRI/2025/10/096668 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Single Dose Three Period Oral Bioequivalence Study comparing Avatrombopag Maleate 20 mg Tablets In Healthy Adult Human Subjects Under Fed 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 of Avatrombopag Maleate 20 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India with Doptelet Avatrombopag 20 mg Tablets Manufactured by AkaRx Inc Morrisville North Carolina 27560 In Healthy Adult Human Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0060-25-AVAT Version No: 01 Date: 18 Jun 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 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 Lifescience and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committe ECR/84/lndt/TN/2013/RR-24 |
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 |
Avatrombopag maleate 20 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India |
A Single oral dose of Avatrombopag maleate 20 mg Tablets will be administered in each period Total Duration is 20 Days |
| Comparator Agent |
DOPTELET Avatrombopag 20 mg Tablets Manufactured by AkaRx Inc Morrisville North Carolina 27560 |
A Single oral dose of DOPTELET Avatrombopag 20 mg Tablets will be administered in each period Total Duration is 20 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human subjects of age between 18 to 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 Non-vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by 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 initiation of the study & a negative urine pregnancy test prior to check-in of each period
If 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 subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
1 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 control as 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 Avatrombopag Maleate 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 which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and 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 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 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 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 start of 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 likely to become pregnant during conduction 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 Average Oral Bioequivalence of Avatrombopag Maleate 20 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India with DOPTELET Avatrombopag 20 mg Tablets Manufactured by AkaRx Inc Morrisville North Carolina 27560 In Healthy Adult Human Subjects Under Fed Conditions |
27 Time points
00.00 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 05.25 Hrs 05.50 Hrs 05.75 Hrs 06.00 Hrs 06.33 Hrs 06.67 Hrs 07.00 Hrs 07.33 Hrs 07.67 Hrs 08.00 Hrs 08.50 Hrs 09.00 Hrs 09.50 Hrs 10.00 Hrs 12.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hrs and 96.00 Hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability in healthy adult human subjects under Fed conditions |
27 Time points
00.00 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 05.25 Hrs 05.50 Hrs 05.75 Hrs 06.00 Hrs 06.33 Hrs 06.67 Hrs 07.00 Hrs 07.33 Hrs 07.67 Hrs 08.00 Hrs 08.50 Hrs 09.00 Hrs 09.50 Hrs
10.00 Hrs 12.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hrs and 96.00 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)
|
10/11/2025 |
| Date of Study Completion (India) |
04/02/2026 |
| 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, adult, human 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 72.00 hours post-dose A washout period of at least 07 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 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 at ambient temperature 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, 04.00, 08.00, 12.00, 24.00 and 48.00 hours (±60 minutes) after completion of the dosing Physical examination, Vitals will be recorded before check-in, check-out (72.00 hours) of each period and at any time if necessary Seated blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded before collection of ambulatory sample at (96.00) hours (±60 minutes) post dose |