| CTRI Number |
CTRI/2024/08/073072 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| 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 Four Period Crossover Fully Replicate Reference Scaled Oral Bioavailability Study Comparing Clopidogrel 75 Mg In 5 Ml Oral Suspension With Plavix Clopidogrel Bisulfate 75 Mg Film Coated Tablets |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Crossover Fully Replicate Reference Scaled Oral Bioavailability Study Comparing Clopidogrel 75 Mg In 5 Ml Oral Suspension Manufactured For Mahashiv Limited Uk With Plavix® Clopidogrel Bisulfate 75 Mg Film Coated Tablets Distributed By Sanofi Aventis Groupe 54 Rue La Boetie F 75008 Paris Frankreich Eu/1/98/069/004 In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0040-24-CLOP version 01 Dated 31 May 24 |
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
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
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
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 |
UK Unit 1 Kataria Point 1 Riches Road llford England IG1 1JH United Kingdom 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 |
Spinos Lifescience and research private limited |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur
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 5/2 Poombugar Nagar Layout 8th Street Thudiyalur Coimbatore 641034 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Under Fasting Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clopidogrel 75 Mg in 5ml |
Clopidogrel 75 mg in 5 mL Oral Suspension single dose oral administration Four Period 15 Days |
| Comparator Agent |
Plavix® |
Clopidogrel Bisulfate 75 mg Film Coated Tablets Single Dose oral administration Four Period 15 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 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 and vital sign assessments
Generally healthy as documented by 12 lead electrocardiogram 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
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 last study related visit
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Clopidogrel Bisulfate 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 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 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 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 Bioavailability on Clopidogrel 75 mg in 5 mL Oral Suspension Manufactured For Mahashiv Limited Uk With Plavix® Clopidogrel Bisulfate 75 mg Film Coated Tablets Distributed by Sanofi Aventis Groupe 54 Rue La Boetie F 75008 Paris Frankreich In Healthy Adult Human Subjects Under Fasting Conditions |
00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 03.50 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 hrs 24.00 Hrs 36.00 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability in healthy adult human subjects under fasting conditions |
00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 03.50 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 hrs 24.00 Hrs 36.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 36
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 36 subjects
in period I |