| CTRI Number |
CTRI/2024/04/065321 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Randomized, two treatment, two sequence, two period, two way
crossover |
|
Scientific Title of Study
|
An open-label, balanced, randomized, two treatment, two sequence, two period, two way
crossover, single oral dose bioequivalence study of fixed-dose combination of Bisoprolol
Fumarate 5 mg Tablets + Perindopril arginine 10 mg Tablets of Servier India Private
Limited and Reference product : EU approved / marketed : Concor (Bisoprolol
Fumarate) 5 mg film-coated tablets of Merck Kft., Hungary and Coversyl (Perindopril
arginine) 10 mg film-coated tablets of Les Laboratoires Servier 50 rue Carnot 92284
Suresnes cedex France, in normal, healthy, adult, human subjects under fasting
conditions |
| Trial Acronym |
BE Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-07-22/2024 |
DCGI |
| PR/BE/23/124, Version no 02 dated 01/03/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raviraj Jagdhani |
| Designation |
Clinical Investigator |
| Affiliation |
Raptim Research Pvt Ltd |
| Address |
Unit A 226 TTC Industrial Area Mahape MIDC Navi Mumbai Unit A
226 TTC Industrial Area Mahape MIDC Navi Mumbai
Mumbai
MAHARASHTRA
400710
India |
| Phone |
02227781889 |
| Fax |
2227781884 |
| Email |
raviraj.jagdhani@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raviraj Jagdhani |
| Designation |
Clinical Investigator |
| Affiliation |
Raptim Research Pvt Ltd |
| Address |
Unit A 226 TTC Industrial Area Mahape MIDC Navi Mumbai Unit A
226 TTC Industrial Area Mahape MIDC Navi Mumbai
Mumbai
MAHARASHTRA
400710
India |
| Phone |
02227781889 |
| Fax |
2227781884 |
| Email |
raviraj.jagdhani@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raviraj Jagdhani |
| Designation |
Clinical Investigator |
| Affiliation |
Raptim Research Pvt Ltd |
| Address |
Unit A 226 TTC Industrial Area Mahape MIDC Navi Mumbai Unit A
226 TTC Industrial Area Mahape MIDC Navi Mumbai
Mumbai
MAHARASHTRA
400710
India |
| Phone |
02227781889 |
| Fax |
2227781884 |
| Email |
raviraj.jagdhani@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| Servier India Private Limited
1703, 17th Floor, Parinee Crescenzo, ‘B’ Wing, Plot Nos. C38 & 39, ‘G’ Block,
Behind MCA, Bandra Kurla Complex, Bandra (East), Mumbai 400 051
|
|
|
Primary Sponsor
|
| Name |
Servier India Private Limited |
| Address |
1703, 17th Floor, Parinee Crescenzo, ‘B’ Wing, Plot Nos. C38 & 39, ‘G’ Block,
Behind MCA, Bandra Kurla Complex, Bandra (East), Mumbai 400 051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Servier India Private Limited |
C/o RV LifeSciences Ltd,
Plot no H-19,MIDC, Waluj
Aurangabad, Maharashtra -431133 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raviraj Jagdhani |
Raptim Research Pvt Ltd |
PAP A 218 and PAP A 219 Screening Facility
A226 Clinical Unit A 242 Bioanalytical and Biostatistical unit TTC Industrial Area Mahape MIDC NaviMumbai - 400710
Mumbai
MAHARASHTRA |
2227781889
2227781884
raviraj.jagdhani@raptimresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Care Independent 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 |
| Comparator Agent |
Reference product (B): Concor (Bisoprolol Fumarate) 5 mg film-coated tablets
tablets of and Coversyl (Perindopril arginine) 10 mg
film-coated tablets |
Following an overnight fast of at least 10.00 hours, subjects will be orally
administered one tablet of either test or one each of reference product with
240 ± 2 mL of drinking water at ambient temperature in an upright sitting
position as per the randomization schedule. |
| Intervention |
Test product (A): Bisoprolol Fumarate 5 mg Tablets + Perindopril arginine
10 mg Tablets (Fixed-dose combination) of Servier India Private Limited. |
Following an overnight fast of at least 10.00 hours, subjects will be orally
administered one tablet of either test or one each of reference product with
240 ± 2 mL of drinking water at ambient temperature in an upright sitting
position as per the randomization schedule. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
Body mass index in the range of 18.50 29.99 kg/m2 (both inclusive)
Normal health status as determined by baseline medical and medication history, at
the time of screening and vital signs measurements and physical examination at the
time of screening as well as check-in of each study period;
Normal or clinically non-significant laboratory values as determined by
hematological, biochemistry tests and urine analysis;
Normal or clinically non-significant 12-lead ECG recording;
Non-smokers or subjects who have no history of smoking for the last one year prior
to check-in;
Willing to abstain from chewing any tobacco containing products at least 72.00 hours
prior to check-in until last sample collection in each study period;
Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to
check-in until last sample collection in each study period;
Willing to abstain from xanthine or its derivative containing food or beverages (e.g.
chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last
sample collection in each study period;
Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in
until last sample collection in each study period;
For female subjects:
Negative urine pregnancy test during screening and negative serum -hCG test at the time of check-in of each study period;
Female subjects with child bearing potential or those within their first two years
of onset of menopausal syndrome willing to either abstain from sexual
intercourse, or should use of acceptable birth control methods for at least 15 days
before 1st check-in till 15 days post last-dose / entire study period. [Acceptable
birth control methods include barrier methods such as diaphragm/condom with or
without spermicide or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy has been performed)]. |
|
| ExclusionCriteria |
| Details |
Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract and of blood forming organs;
Significant history or current evidence of malignancy or chronic - infectious,
cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic
(endocrine), hematological, gastrointestinal, dermatological, immunological or
psychiatric diseases, or organ dysfunction;
Any major illness or hospitalized within 90 days prior to the first check-in;
Requiring medication for any ailment having enzyme-modifying activity within one
month prior to first check-in and throughout the study;
Use of any depot injection or an implant of any drug within 3 months prior to first
check-in and throughout the study;
Use of any prescribed medication (including herbal medicines and vitamin
supplements) or OTC products within 30 days prior to first check-in and throughout
the study;
History or presence of significant gastric and/or duodenal ulceration;
Difficulty in swallowing tablets or capsules;
Use of any recreational drug or history of drug addiction;
Participated in any clinical investigation requiring repeated blood sampling or have
donated blood in past 90 days prior to first check-in;
Positive breath alcohol and urine drug of abuse tests during check-in of each study
period;
Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or
Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
Lactating or nursing female subjects;
Female subjects using hormonal contraceptive (either oral/implants);
History of allergy or hypersensitivity intolerance to Bisoprolol Fumarate and
Perindopril Arginine or its formulation excipients which, in the opinion of a clinical
investigator, would compromise the safety of the subject or the study;
History of difficulty in accessibility of veins in arms. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess bioequivalence of the test product in comparison
with the reference product |
For Bisoprolol and Perindoprilat 0.000(within 2.000 hours prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 8.000 12.000 16.000 24.000 36.000 48.000 and 72.000 hrs post dose.
For Perindopril 0.000 (within 2.000 hrs prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 and 8.000 hrs post dose. A washout period of at least 14 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess safety and tolerability of the Test Product in comparison with the EU approved Reference Product. |
For Bisoprolol and Perindoprilat 0.000(within 2.000 hours prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 8.000 12.000 16.000 24.000 36.000 48.000 and 72.000 hrs post dose.
For Perindopril 0.000 (within 2.000 hrs prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 and 8.000 hrs post dose. A washout period of at least 14 days. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
20/04/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Servier India Private Limited has developed a fixed dose combination tablet containing Bisoprolol 5mg and Perindopril arginine 5 mg tablets and Bisoprolol 5 mg and Perindopril arginine 10 mg tablets as a bi-layered tablet.
Therefore, Servier India is proposing to conduct An open-label, balanced, randomized, two treatment, two sequence, two period, two way crossover, single oral dose bioequivalence study of fixed-dose combination of Bisoprolol Fumarate 5 mg Tablets + Perindopril arginine 10 mg Tablets of Servier India Private Limited and Reference product : EU approved / marketed : Concor (Bisoprolol Fumarate) 5 mg film-coated tablets of Merck Kft., Hungary and Coversyl (Perindopril arginine) 10 mg film-coated tablets of Les Laboratoires Servier 50 rue Carnot 92284 Suresnes cedex France, in normal, healthy, adult, human subjects under fasting conditions. |