CTRI/2022/12/048435 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On:
27/06/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A Bioequivalence study of Dapagliflozin 10mg and Gliclazide 60mg Sustained release tablets on healthy human volunteers to compare the plasma concentrations between test product and marketed product.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin 10mg and Gliclazide Sustained Release tablets 60 mg (T) Manufactured by Eris Lifesciences Ltd, India with Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Marketed by AstraZeneca Pharma India Ltd., India and Diamicron® XR 60mg (Gliclazide extended release tablet) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human subjects under fasting condition.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
S-22-734 Version 01 Dated- 13-Sep-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Harisha C
Designation
MBBS, Clinical Investigator
Affiliation
Notrox Research Pvt Ltd
Address
No 19-3,2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road (Behind Metro Cash & carry)
Bangalore KARNATAKA 560062 India
Phone
Fax
Email
harisha-c@notroxresearch.com
Details of Contact Person Scientific Query
Name
Ganesh Boddu
Designation
Head- Regulatory Affairs and Clinical Research
Affiliation
Eris Lifesciences Ltd.
Address
Eris Lifescience Ltd, Shivarth Ambit, Ramdas Road Off SBR
Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat
Bangalore KARNATAKA 380054 India
Phone
Fax
Email
Ganesh.boddu@erislifesciences.com
Details of Contact Person Public Query
Name
Ganesh Boddu
Designation
Head- Regulatory Affairs and Clinical Research
Affiliation
Eris Lifesciences Ltd.
Address
Eris Lifescience Ltd, Shivarth Ambit, Ramdas Road Off SBR
Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat
Bangalore KARNATAKA 380054 India
Phone
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
Eris Lifescience Ltd., Brahmaputra Industrial Park, Village-Silla, Amingaon, North Guwahati, Assam-781031.
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 Harisha C
Notrox Research Pvt Ltd
No 19/3,2nd Floor, Bikasipura road,
JC Industrial layout, off Kanakapura Road (Behind Metro Cash & carry)
Bangalore -560062
Bangalore KARNATAKA
9845933077
harisha-c@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 adult human subjects
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dapagliflozin 10mg and Gliclazide Sustained Release tablets 60 mg.
After an overnight fasting of at least 10.00 hours, a single Dapagliflozin 10mg and Gliclazide Sustained Release tablets 60 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.
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.
Comparator Agent
Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Marketed by: AstraZeneca Pharma India Ltd., India. Diamicron® XR 60mg (Gliclazide extended release tablet) (R2)
Manufactured by: Serdia Pharmaceuticals (India) Pvt, Ltd., India.
After an overnight fasting of at least 10.00 hours, a single Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Marketed by AstraZeneca Pharma India Ltd., India and Diamicron® XR 60mg (Gliclazide extended release tablet) (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.
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, 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 30.00 kg/m2 (both inclusive) at the time of screening.
3. Normal or clinically insignificant findings during screening, medical history, medical examination, 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.
7. Preferably non smoker and non alcoholic.
In case of Female subjects:
8. Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation.
9. Female subjects who are of childbearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
10. Female subjects who are tested negative for serum pregnancy test at the time of check-in.
11. Female subjects who are tested negative for urine pregnancy test at the time of screening.
12. Female subjects who has surgically sterilized partner (for at least 6 months).
ExclusionCriteria
Details
If any subject is having any of the following conditions, then exclude him/her 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. Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
4. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
5. Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening.
6. Respiratory rate below 12 or above 20 breaths per minute at the time of screening.
7. Body temperature below 96.2o F or above 99.8 o F at the time of screening.
8. SpO2 less than 94% @ RA at the time of screening.
9. Ingestion of any medicine at any time within 14 days prior to IP administration
10. in period I. In any such case subject selection will be at the discretion of the principal investigator.
11. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
12. Smokers who smoke >9 cigarettes per day.
13. Alcoholic who consumes >21units of alcohol in a week.
14. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
15. 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.
16. The presence of clinically significant abnormal laboratory values during screening.
17. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
18. A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
19. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
20. Difficulty in swallowing capsule/tablet.
21. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
22. 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.
23. History of undiagnosed vaginal bleeding (for females only).
24. Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.
25. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
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 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected in each period.
The post-dose blood samples of 4.0 mL will be collected 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, 72.00 and 96.00 hours post-dose.
36.00, 48.00, 72.00 and 96.00 hours ambulatory visit. (window period as ± 60 minutes).
Secondary Outcome
Outcome
TimePoints
Tmax, Kel, t½ and AUC% Extrap obs(%)
Total 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected in each period.
The post-dose blood samples of 4.0 mL will be collected 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, 72.00 and 96.00 hours post-dose.
36.00, 48.00, 72.00 and 96.00 hours ambulatory visit. (window period as ± 60 minutes).
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin 10mg and Gliclazide Sustained Release tablets 60 mg (T) Manufactured by Eris Lifesciences Ltd, India with Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Marketed by AstraZeneca Pharma India Ltd., India and Diamicron® XR 60mg (Gliclazide extended release tablet) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human subjects under fasting condition.