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CTRI Number  CTRI/2022/11/047234 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 11/02/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Dapagliflozin and Vildagliptin Sustained-Release Tablets. 
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 Vildagliptin Sustained Release tablets 100 mg (T) Manufactured by Eris Lifesciences Ltd, India with Zomelis-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg) (R) Manufactured by Exemed Pharmaceuticals., India in normal healthy, adult human subjects under fasting condition 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
S-22-733, Version No. 01, dated 13-09-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harisha C 
Designation  PI 
Affiliation  Notrox Research Pvt. Ltd. 
Address  Bikasipura road, JC Industrial layout, off Kanakapura Road

Bangalore
KARNATAKA
560062
India 
Phone    
Fax    
Email  harisha-c@notroxresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Ganesh Boddu 
Designation  Head- Clinical and Regulatory Affairs 
Affiliation  Eris Lifesciences Ltd. 
Address  Shivarth Ambit, Ramdas Road Off SBR, Near Swati Bungalows, Bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone    
Fax    
Email  Ganesh.boddu@erislifesciences.com  
 
Details of Contact Person
Public Query  
Name  Ganesh Boddu 
Designation  Head- Clinical and Regulatory Affairs 
Affiliation  Eris Lifesciences Ltd. 
Address  Shivarth Ambit, Ramdas Road Off SBR, Near Swati Bungalows, Bodakdev


GUJARAT
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- 380054  
 
Primary Sponsor  
Name  Eris Lifesciences Ltd. 
Address  Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev, Ahmedabad- 380054  
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.  2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road Bangalore,560062, Karnataka India
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 Human Volunteers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg  After an overnight fasting of at least 10.00 hours, a single Dapagliflozin 10 mg and Vildagliptin Sustained Release tablets 100 mg (T) Manufactured by Eris Lifesciences Ltd, India 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. 
Comparator Agent  Zomelis-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg)   After an overnight fasting of at least 10.00 hours, a singleZomelis®-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg) (R) Manufactured by Exemed Pharmaceuticals., 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. 
 
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.
8. In case of Female subjects:
Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation.
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.
Female subjects who are tested negative for serum pregnancy test at the time of check-in.
Female subjects who are tested negative for urine pregnancy test at the time of screening.
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 24 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 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and
48.00 hours post-dose.

36.00 and 48.00 hours ambulatory visit. (window period as ± 60 minutes) 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax, Kel, t½ and AUC% Extrap obs(%)  Total 24 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 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.

36.00 and 48.00 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" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/11/2022 
Date of Study Completion (India) Date Missing 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet planned 
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 Vildagliptin Sustained Release tablets 100 mg (T) Manufactured by Eris Lifesciences Ltd, India with Zomelis®-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg) (R) Manufactured by Exemed Pharmaceuticals., India in normal healthy, adult human subjects under fasting condition. 
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