CTRI/2024/12/077770 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On:
28/11/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
NA
Study Design
Randomized, Crossover Trial
Public Title of Study
A Study to evaluate the blood levels of Sitagliptin 100 mg + Gliclazide SR 60 mg + Metformin HCL SR 500 mg tablet as a Test compared to the Reference-1 (ALSITA-M 100) + Reference-2 (Diamicron XR 60) tablets in a healthy subject under fasting conditions.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two-period, cross-over, single-dose, oral bioequivalence study of Sitagliptin tablets 100 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg (T) Manufactured by Eris Lifesciences Ltd., India with ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by Alkem Health Science., India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal
healthy, adult human male subjects under fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
S-24-841, Version 01, dated 29 Jan 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Divya A
Designation
MD, Clinical Investigator
Affiliation
Notrox Research Pvt Ltd
Address
Notrox Research Pvt Ltd
No 19/3,2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road (Behind Metro Cash & carry) Bangalore -560062,
Karnataka state, India.
Bangalore KARNATAKA 560062 India
Phone
918667531468
Fax
Email
drdivya-a@notroxresearch.com
Details of Contact Person Scientific Query
Name
Mr Ganesh Boddu
Designation
Head- Clinical Research and Regulatory Affairs
Affiliation
Eris Lifesciences Ltd
Address
Eris Lifescience Ltd., Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat-380054, India
Ahmadabad GUJARAT 380054 India
Phone
9676559480
Fax
Email
ganesh.boddu@erislifesciences.com
Details of Contact Person Public Query
Name
Mr Ganesh Boddu
Designation
Head- Clinical Research and Regulatory Affairs
Affiliation
Eris Lifesciences Ltd
Address
Eris Lifescience Ltd., Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat-380054, India
Ahmadabad GUJARAT 380054 India
Phone
9676559480
Fax
Email
ganesh.boddu@erislifesciences.com
Source of Monetary or Material Support
Eris Lifesciences Ltd, Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev,Ahmedabad,Gujarat 380054, India
Primary Sponsor
Name
Eris Lifesciences Ltd
Address
Plot No. 30-31, Brahmaputra Industrial Park, Village-Silla, Amingaon, North Guwahati, Dist-Kamrup, Assam-781031, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Divya A
Notrox Research Pvt. Ltd.
No 19/3, 2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road (Behind Metron cash & carry), Bangalore-560062, Karnataka, India. Bangalore KARNATAKA
8667531468
drdivya-a@notroxresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sri Durgamba Independent ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
(Reference-1) ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg Mfg by Alkem Health Science. (Reference-2) Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) Mfg by Serdia Pharmaceuticals (India) Pvt, Ltd.
After an overnight fasting of at least 10.00 hours, a single dose of ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended-Release Tablets 500 mg) (R1) Manufactured by Alkem Health Science., India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. The Total duration of the study for each subject will be 15 days from the day of check-in of the first period till the Last sample of the second period.
After an overnight fasting of at least 10.00 hours, a single dose of Sitagliptin tablets 100 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg (T) Manufactured by Eris Lifesciences Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. The Total duration of the study for each subject will be 15 days from the day of check-in of the first period till the Last sample of the second period.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Volunteers who accept for participating in this study must:
1) Healthy, adult human, male subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2) Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
3) Normal or clinically insignificant findings during screening, medical history, and clinical examination including vital signs, laboratory evaluations, 12 lead ECG, and X-ray chest (posterior-anterior view) recordings.
4) Able to comply with the study procedures, in the opinion of the principal investigator.
5) Compliance with study-specific restrictions and prohibitions.
6) Able to give voluntary written informed consent for participation in the trial.
ExclusionCriteria
Details
If any subject is having any of the following conditions, then exclude him from participation in this study:
1) Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2) History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
3) Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case, subject selection will be at the discretion of the principal investigator.
4) Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
5) Smokers and Alcoholics.
6) History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
7) An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
8) The presence of clinically significant abnormal laboratory values during screening.
9) Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
10) A history of difficulty with donating blood or having donated blood in the preceding 90 days for males prior to the start of the study.
11) Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males preceding the start of the study.
12) Difficulty in swallowing capsule/tablet.
13) Positive HIV, VDRL/RPR, Hepatitis B and C tests.
14) Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC(0-t) and AUC(0-inf)
Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected and placed in Ice cold bath at each period.
The post-dose blood samples of 5.0 mL will be collected and placed in Ice cold bath at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
Secondary Outcome
Outcome
TimePoints
Tmax, Kel, t½ and AUCExtrapolated%
Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected and placed in Ice cold bath at each period.
The post-dose blood samples of 5.0 mL will be collected and placed in Ice cold bath at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
Target Sample Size
Total Sample Size="32" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "32" Final Enrollment numbers achieved (India)="32"
Phase of Trial
N/A
Date of First Enrollment (India)
16/12/2024
Date of Study Completion (India)
07/01/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
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
After an overnight fasting of at least 10.00 hours, a single dose of Sitagliptin tablets 100 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg (T) Manufactured by Eris Lifesciences Ltd., India or ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by Alkem Health Science., India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
Note: Investigational products should be administered with 240±2 mL of a 20% aqueous glucose solution, followed by 60 mL of the 20% aqueous glucose solution administered every 15 minutes (window period of ± 5 minutes) for upto 04 hours after dosing.