| CTRI Number |
CTRI/2024/08/072877 [Registered on: 22/08/2024] 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
|
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 |
|
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 Swedish Orphan Biovitrum Ab Publ Stockholm Sweden Se 11276 In Healthy Adult Human Subjects Under Fed Conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0026-23-AVAT version 01 22 Aug 23 |
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
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| 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
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| 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
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Spinos Life Science And Research Private Limited
29 A Krishna Maduravanam Vellakinar Pirivu Coimbatore 641029 |
|
|
Primary Sponsor
|
| Name |
BDR Pharmaceuticals Internationals Pvt Ltd |
| Address |
Engineering Centre 6th floor
9th Matthew Road
Opera House Mumbai 400004
India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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
29 A Krishna Maduravanam Vellakinar Pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
8220586899
pradeeep.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 Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AVATROMBOPAG MALEATE |
20 Mg Tablets Oral Dose Single Administration |
| Comparator Agent |
DOPTELET |
20 Mg Tablets Oral Dose Single Administration |
|
|
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 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
|
|
| 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 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 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
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
|
|
|
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 Swedish Orphan Biovitrum AB Stockholm Sweden SE 11276 In Healthy Adult Human Subjects Under Fed Conditions |
00.50 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.33 Hrs 04.67 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 08.00 hrs 12.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hrs 96.00 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Asses the Safety And Tolerability |
00.50 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 04.33 Hrs 04.67 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 08.00 hrs 12.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 72.00 Hrs 96.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/09/2024 |
| Date of Study Completion (India) |
01/10/2024 |
| 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
|
Enough volunteers shall be recruited in order to evaluate and start the study with at least 42 subjects, as this Bioequivalence study will be conducted on healthy, adult, human subjects. As per the discretion of Investigator, additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 42 subjects in period I.
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 07 days from the successive dosing day.
|