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CTRI Number  CTRI/2026/01/102382 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   NA 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study in healthy volunteers to compare two medicines (Dapagliflozin, Metoprolol) used for heart conditions when taken without food. 
Scientific Title of Study   A Randomized Open Label Balanced Two Treatment Two Period Two Sequence Single Dose Crossover Oral Bioequivalence Study of Dapagliflozin 10 mg Metoprolol Succinate 25 mg Sustained Release Fixed Dose Combination Tablets Test Product T Dapagliflozin 10 mg and Metoprolol Succinate SR 25 mg Tablet Manufactured by Eris Lifesciences Limited India with Reference Product R Dapaglyn MX 25 Dapagliflozin 10 mg Metoprolol Succinate 25 mg Tablets Manufactured by Exemed Pharmaceuticals India in Healthy Adult Male Human Subjects under Fasting Condition 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SY/24/29, Version 02, dated 25 Aug 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirav Panchal 
Designation  MBBS, Clinical Investigator 
Affiliation  Sycon Clinical Research Pvt Ltd. 
Address  Sycon Clinical Research Pvt. Ltd. 5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, Gandhinagar-382421, Gujarat, India

Gandhinagar
GUJARAT
382421
India 
Phone  09879503898  
Fax    
Email  niravp@syconcro.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ganesh Boddu 
Designation  Head- Clinical Research and Regulatory Affairs  
Affiliation  Eris Lifesciences Limited 
Address  Eris Lifesciences Limited ,Shivarth Ambit, Ramdas Road Off SBR, Near Swati Bungalows, Bodakdev,

Ahmadabad
GUJARAT
380054
India 
Phone  09676559480  
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 Limited 
Address  Eris Lifesciences Limited ,Shivarth Ambit, Ramdas Road Off SBR, Near Swati Bungalows, Bodakdev,

Ahmadabad
GUJARAT
380054
India 
Phone  09676559480  
Fax    
Email  ganesh.boddu@erislifesciences.com  
 
Source of Monetary or Material Support  
Eris Lifesciences Ltd., 1st Floor-101, Shivarth Ambit, Opp. Janvi Bunglows, Nr. Mann Party Plot, Sindhubhavan Road, Gujarat (India) - 380054 
 
Primary Sponsor  
Name  Eris Lifesciences Limited 
Address  Plot No. 30-31, Brahmaputra Industrial Park, Village-Sila, Amingaon, Dist. Kamrup, 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 Nirav Panchal  Sycon Clinical Research Private Limited  5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, Gandhinagar-382421, Gujarat, India
Gandhinagar
GUJARAT 		 09879503898

niravp@syconcro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACES-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 product (R):Dapaglyn®MX 25 (Dapagliflozin 10 mg + Metoprolol Succinate 25 mg ) Tablets, oral dosage form total intervention of study is 11 day  Subjects will fast overnight from at least 10.00 hrs. A single oral dose of Reference product (R) will be administered as per randomization schedule with 240 mL ± 2 mL of a 20% glucose solution in water at ambient temperature under fasting condition. Considering the minimum washout period 07 days, expected study duration of clinical part is 11 days from the day of check-in of first period till the day of last period study sample 
Intervention  Test product (T): Dapagliflozin 10 mg and Metoprolol Succinate (SR) 25 mg Tablets, oral dosage form total intervention of study is 11 days  Subjects will fast overnight from at least 10.00 hrs. A single oral dose of Test product (T) will be administered as per randomization schedule with 240 mL ± 2 mL of a 20% glucose solution in water at ambient temperature under fasting condition. Considering the minimum washout period 07 days, expected study duration of clinical part is 11 days from the day of check-in of first period till the day of last period study sample 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Healthy male human subjects, age in the range of 18 - 45 years both inclusive.
2. Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 48 kg weight.
3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry including creatinine clearance, urinalysis, 12 lead ECG and chest X-ray (if done).
5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions.
6. No history of significant alcoholism.
7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
8. Non-smokers as evident from the history obtained.
9. Willing to provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Known history of hypersensitivity to Dapagliflozin and Metoprolol Succinate or related drugs or any of the excipients.
2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
6. Not eligible as per OVIS.
7. Volunteer who have donated blood or loss of blood up to 150 ml within 30 days or in between 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study medication.
8. History of malignancy or other serious diseases.
9. Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening.
10. Found positive in breath alcohol test and/or urine test for drug abuse.
11. History of problem in swallowing of tablet/capsule.
12. Any contraindication to blood sampling.
13. Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
14. Use of hormonal contraceptives either oral or implants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC(0-t) and AUC(0-inf)  Total number of blood samples: 22 samples per period.
Sampling hrs: Pre dose [(7 mL) collected within 01.00 hour prior to dosing] and post dose of 5 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer.
 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax, Kel, t½ and AUCExtrapolated%  Total number of blood samples: 22 samples per period.
Sampling hrs: Pre dose [(7 mL) collected within 01.00 hour prior to dosing] and post dose of 5 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer.
 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) 02/04/2026 
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   This is a randomized, open-label, two-treatment, two-period, single-dose crossover bioequivalence study to compare Dapagliflozin 10 mg + Metoprolol Succinate SR 25 mg tablets manufactured by Eris Lifesciences Ltd. with the reference product Dapaglyn MX 25 under fasting conditions in 36 healthy adult male subjects.

Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf) will be evaluated using validated bioanalytical methods. Bioequivalence will be conducted if 90% confidence intervals for test/reference ratios fall within 80.00%-125.00%. safety will be monitored through clinical assessments, laboratory tests, and adverse event reporting in compliance with CDSCO and ICP-GCP guidelines. 
 
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