| CTRI Number |
CTRI/2023/02/049496 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Open Label,Balanced,Randomized,Single-Dose,Two-Treatment, Crossover Oral BE Study |
| Study Design |
Other |
|
Public Title of Study
|
Randomized, Crossover Trial |
|
Scientific Title of Study
|
An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period,
Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended Release
Tablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD
(Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets
(Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human Male
Subjects Under Fasting Conditions. |
| Trial Acronym |
BA/BE Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 320-22, version no 00 dated 17-Aug-2022 |
Protocol Number |
| Amendment no 01 dated 21-Nov-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNageshwar HulgundeMBBS |
| Designation |
Principal Investigator |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd |
| Address |
BioRadius Therapeutic Research Pvt. Ltd
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I,Pune
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I,
Pune
MAHARASHTRA
411057
India |
| Phone |
02067789100 |
| Fax |
|
| Email |
nageshwarhulgunde@bioradiuscro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNageshwar HulgundeMBBS |
| Designation |
Principal Investigator |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd |
| Address |
BioRadius Therapeutic Research Pvt. Ltd
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I,Pune
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I
Pune
MAHARASHTRA
411057
India |
| Phone |
02067789100 |
| Fax |
|
| Email |
nageshwarhulgunde@bioradiuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNageshwar HulgundeMBBS |
| Designation |
Principal Investigator |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd |
| Address |
BioRadius Therapeutic Research Pvt. Ltd
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I,Pune
IndiaLand Global Industrial Park;
Plot No.8, S.No. 234,235,245,
Hinjawadi Phase I,
Pune
MAHARASHTRA
411057
India |
| Phone |
02067789100 |
| Fax |
|
| Email |
nageshwarhulgunde@bioradiuscro.com |
|
|
Source of Monetary or Material Support
|
| BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park,
Plot No.8, S.No. 234, 235, 245,
Hinjewadi Phase I,
Pune- 411057, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Servier India Private Limited |
| Address |
1703 17th Floor Parinee Crescenzo B Wing Plot no C 38 & 39 G Block Behind MCA Bandra Kurla Complex Bandra East Mumbai
400051 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrNageshwar Hulgunde |
BioRadius Therapeutic Research Pvt. Ltd |
India Land Global Industrial Park, Plot No 8, S No 234, 235, 245,Hinjewadi Phase 1,
Pune
MAHARASHTRA |
02067789100
nageshwarhulgunde@bioradiuscro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKINOVATE 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
Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets (Indian innovator) Manufactured by IPCA Laboratories |
Subjects will be housed in the clinical facility from at least -36.00 hours prior
to dosing and will continue to remain in the clinical facility till at least 48.00
hours after dosing.
The subject will stay for 04 consecutive nights in the facility in each period.
This is a two-period study with at least 10 days washout period between each
successive dosing day.
Total expected duration of the study for the subject
will be of at least 17 days from the day of admission into the clinic (checking of period-I) till the period-II check-out of the study. |
| Intervention |
Test Product-
Gliclazide and Metformin Extended Release Tablets 60 mg / 500mg manufactured
by Servier India Private Limited. |
Subjects will be housed in the clinical facility from at least -36.00 hours prior to dosing and will continue to remain in the clinical facility till at least 48.00 hours after dosing. The subject will stay for 04 consecutive nights in the facility in each period. This is a two-period study with at least 10 days washout period between each successive dosing day. Total expected duration of the study for the subject will be of at least 17 days from the day of admission into the clinic (checking of period-I) till the period-II check-out of the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Healthy male human adult subjects (of 18 to 45 years of age (both inclusive) and weight
of at least 50 kg.
Capable and willing to give informed written consent and to adhere to the study
requirements.
Body Mass Index (BMI) between 18.50 30.00 Kg/m2.
Healthy individuals as evaluated by personal history, medical history and general
clinical examination.
Absence of significant disease or clinically significant abnormal laboratory values or
laboratory evaluation, medical history or physical examination judged by investigator.
Normal biochemical, haematological and urinary parameters or with abnormality
considered to be clinically not significant and performed within 21 days prior to dosing
of first period of the study.
Have a normal 12 lead ECG or with an abnormality considered to be clinically not
significant.
Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and
Syphilis.
Non-smoker (for at least 6 months prior to first drug administration).
Ability to fast for at least 14.00 hours and consume standard meals. |
|
| ExclusionCriteria |
| Details |
History of any medical disorder that is of significance in the invesigators opinion.
Recent history of urinary retention, severe gastro-intestinal condition (including toxic
mega colon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia.
History of any major surgical procedure in the past 3 months.
History of diabetes mellitus, tuberculosis and systemic hypertension.
History of any medication for treatment of joint pain, inflammation, stone in kidney or
urinary tract prior to one month of screening day
History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine,
metabolic, psychiatric or hematological illnesses, judged to be clinically significant.
Recent history of dehydration from diarrhea, vomiting or any other reason within a period
of 24 hours prior to the study.
History of dysphasia.
History or presence of cancer.
Difficulty in donating blood
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide
and Metformin Extended Release Tablets 60 mg / 500 mg tablets manufactured by Servier
India Private Limited (Test Product) and Glycinorm M OD (Gliclazide Modified Release
and Metformin Extended Release Tablets 60 mg / 500mg) tablets manufactured by IPCA
Laboratories, India in healthy, adult, human male subjects under fasting conditions |
17 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a single dose administered in healthy,adult, human male subjects under fasting conditions. |
Day 1 to Day 17 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/02/2023 |
| Date of Study Completion (India) |
13/02/2023 |
| 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
|
Not Applicable |
|
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 gliclazide 60 mg with metformin 500 mg ( both extended release) as a bi-layered tablet. Similar product is approved in India manufactured and marketed by IPCA Laboratories. The proposed project is An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended Release Tablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets (Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human Male Subjects Under Fasting Conditions. |