CTRI/2024/02/062469 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On:
10/04/2025
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 Dapagliflozin 10mg + Vildagliptin 100mg + Metformin 1000mg tablet as a Test compared to the Zomelis-DM Forte (Dapagliflozin 10mg + Vildagliptin 100mg + Metformin 1000mg) tablet as a Reference in a healthy subject under fasting conditions.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose, oral bioequivalence study of FDC of Vildagliptin Sustained Release 100mg, Dapagliflozin 10mg and Metformin Hydrochloride Sustained Release 1000mg Tablets (T) Manufactured By Eris Lifesciences Ltd., India with Zomelis®-DM Forte (Vildagliptin(As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100mg + 10mg + 1000mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, India in normal healthy, adult human subjects under fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
S-23-820, Version 01, dated 01 Sep 2023
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
Notrox Research Pvt. Ltd. No 19-3,2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road, Behind Metro Cash and carry, Bangalore, KARNATAKA-560062, India
Bangalore KARNATAKA 560062 India
Phone
7760829333
Fax
Email
harisha-c@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
9696661436
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.
GUJARAT 380054 India
Phone
9696661436
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 Harisha C
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
7760829333
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
Normal Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Reference Product: Zomelis® - DM Forte (Vildagliptin (As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100 mg + 10 mg + 1000 mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, India.
After an overnight fasting of at least 10.00 hours, a single dose of Zomelis® - DM Forte (Vildagliptin (As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100 mg + 10 mg + 1000 mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, 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 and followed by 60 mL of the 20% aqueous glucose solution administered every 15 minutes (window period of ± 5 minutes) for up to 04 hours after dosing. The Total duration of the study for each subject will be 11 days from the day of check-in of the first period till the Last sample of the second period.
Intervention
Test Product: Fixed Dose Combination of Vildagliptin Sustained Release 100 mg, Dapagliflozin 10 mg and Metformin Hydrochloride Sustained Release 1000 mg Tablets (T) Manufactured by Eris Lifesciences Ltd., India
After an overnight fasting of at least 10.00 hours, a single dose of FDC of Vildagliptin Sustained Release 100 mg, Dapagliflozin 10 mg, and Metformin Hydrochloride Sustained Release 1000 mg Tablets (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 and 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. The Total duration of the study for each subject will be 11 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, subjects aged between 18-45 years (both inclusive) 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, 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.
In the case of Female subjects:
(1) Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra-uterine device during the study.
(2) Female subjects who are tested negative for serum pregnancy test at the time of check-in.
(3) Female subjects who are tested negative for urine pregnancy test at the time of screening.
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) 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 / 120 days for females 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 / 120 days for females 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.
(15) Pregnant and lactating women or those using hormonal contraceptives (oral/implants).
(16) History of undiagnosed vaginal bleeding (for females only).
(17) Female subjects who demonstrate a positive pregnancy during screening or currently breast-feeding.
(18) 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 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected in Ice cold bath at each
period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers.
The post-dose blood samples of 5.0 mL will be collected in Ice cold bath at 00.33, 00.67, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00,
04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 12.00, 16.00, 20.00, 24.00, 30.00, 36.00, 48.00 hours post-dose
Secondary Outcome
Outcome
TimePoints
Tmax, Kel, t½ and AUCExtrapolated%
Total 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected in Ice cold bath at each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers.
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "24" Final Enrollment numbers achieved (India)="24"
After an overnight fasting of at least 10.00 hours, a single dose of FDC of Vildagliptin Sustained Release 100 mg, Dapagliflozin 10 mg and Metformin Hydrochloride Sustained Release 1000 mg Tablets (T) Manufactured by Eris Lifesciences Ltd., India or Zomelis® - DM Forte (Vildagliptin (As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100 mg + 10 mg + 1000 mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, 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.