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CTRI Number  CTRI/2023/06/054073 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 17/06/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Sitagliptin 100 mg Metformin Hydrochloride 1000 mg extended release Tablets of SunGlow Lifescience Private Ltd in comparison with Janumet XR 100 mg 1000 mg tablets Sitagliptin and metformin HCl extended release tablets in healthy adult subjects in fed condition  
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private Ltd., in comparison with Janumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/040/0922, Version 00, 13 Sep 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya R 
Designation  Principal Investigator 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  pi.mail@icbiocro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish S 
Designation  Director Operation 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish S 
Designation  Director Operation 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
SunGlow Lifescience Private Ltd S.No.208/1A, 208/2A1B, 220/3B, Kattankulam Village, Nelvoy-Thirumukkoodal Road), Uthiramerur (TK) Kanchipuram (Dist.), Pin: 631 606, Tamil Nadu, India  
 
Primary Sponsor  
Name  SunGlow Lifescience Private Ltd 
Address  S.No.208/1A, 208/2A1B, 220/3B, Kattankulam Village, Nelvoy-Thirumukkoodal Road), Uthiramerur (TK) Kanchipuram (Dist.), Pin: 631 606, Tamil Nadu, India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
SunGlow Lifescience Private Ltd   S.No.208/1A, 208/2A1B, 220/3B, Kattankulam Village, Nelvoy-Thirumukkoodal Road), Uthiramerur (TK) Kanchipuram (Dist.),  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya R  ICBio Clinical Research Pvt Ltd   Clinical department 1st floor #16&18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA 		 9900111997

pi.mail@icbiocro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fed condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Janumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets   Name of the drug: Sitagliptin 100 mg and metformin HCl 1000 mg Route of administration: Oral Frequency: Single dose Duration of clinical study: 11 days 
Intervention  Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets   Name of the drug:Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets Route of administration: Oral Frequency: Single dose Duration of clinical study: 11 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
2. Willing to be available for the entire study period and to comply with protocol requirements.
3. Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
4. Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
5. Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
 
 
ExclusionCriteria 
Details  1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
3. History of severe infection or major surgery in the past 6 months.
4. History of Minor surgery or fracture within the past 3 months.
5. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞  from Day 01 to Day 11 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2  From Day 01 to Day 11 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="11" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   STUDY TITLE:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private Ltd., in comparison with Janumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions
OBJECTIVES:

Primary objective:

To compare the rate and extent of absorption of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private Ltd., with that of Janumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed condition.

Secondary objective:

To monitor the safety and tolerability of the study subjects after administration of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets in healthy, adult, human subjects under fed condition.

Number of subjects: Thirty two (32)
Duration of clinical study: 11 days
 
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