| CTRI Number |
CTRI/2024/09/074038 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| 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 Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Apixaban 5 mg Oral Solution 1mg/mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi India |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Apixaban 5 Mg Oral Solution 1mg Per Ml Manufactured By Xl Laboratories Pvt Ltd 430 Dlf Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 Mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer Eeig Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0039-24-APIX Version No 02 date 17 May 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spino Life science and research private limited |
| Address |
Spinos life science and Research Private limited
Ground floor No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore - 641029 Tamil Nadu India
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 |
Spino Life science and research private limited |
| Address |
Spinos life science and Research Private limited
Ground floor No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore - 641029 Tamil Nadu India
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 |
Spino Life science and research private limited |
| Address |
Spinos life science and Research Private limited
Ground floor No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore - 641029 Tamil Nadu India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Mahashiv Limited
UK Unit 1
Kataria Point
1 Riches Road llford
England IG1 1JH
|
|
|
Primary Sponsor
|
| Name |
Mahashiv Limited |
| Address |
Mahashiv Limited
UK Unit 1
Kataria Point
1 Riches Road llford
England IG1 1JH |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| 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 |
SpinosLife Science research Private Limited |
Clinical Pharmacology Unit
Ground floor
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India
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 |
Fasting Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apixaban 5 mg Oral Solution (1mg/ml) |
Apixaban 5 mg Oral Solution 1 mg/ml single dose oral administration |
| Comparator Agent |
Eliquis (Apixaban) 5 mg Film Coated Tablets |
Eliquis (Apixaban) 5 mg Film Coated Tablets single dose oral 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 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 30.00 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 Non smokers
Generally healthy as documented by gynaecological examination and breast examination
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Apixaban 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 History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products coffee tea chocolate and caffeine containing sodas cola 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 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
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
|
|
|
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 Bioavailability on Apixaban 5 mg Oral Solution 1mg/mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions |
23 blood samples
00.00 hrs 00.25 hrs 00.50 hrs 00.75 hrs 01.00 hrs 01.33 hrs 01.67nhrs 02.00 hrs 02.33 hrs 02.67 hrs 03.00 hrs 03.33 hrs
03.67 hrs 04.00 hrs 04.50 hrs 05.00 hrs 06.00 hrs 08.00 hrs 12.00 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 single dose administered in healthy adult human subjects under fasting conditions |
23 blood samples
00.00 hrs 00.25 hrs 00.50 hrs 00.75 hrs 01.00 hrs 01.33 hrs 01.67nhrs 02.00 hrs 02.33 hrs 02.67 hrs 03.00 hrs 03.33 hrs
03.67 hrs 04.00 hrs 04.50 hrs 05.00 hrs 06.00 hrs 08.00 hrs 12.00 hrs 24.00 hrs 36.00 hrs 48.00 hrs and 72.00 hrs
|
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2024 |
| Date of Study Completion (India) |
29/11/2024 |
| 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 28 subjects, as this Bioavailability 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 28 subjects in period I. In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 04 days from the successive dosing day.
|