| CTRI Number |
CTRI/2024/10/075543 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| 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 50 mg and Metformin Hydrochloride 500 mg Extended release tablets in healthy adult human subjects under fed conditions. |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral
bioequivalence study of Sitagliptin 50 mg & Metformin
Hydrochloride 500 mg (extended release) Tablets by SunGlow
Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg
tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg} of Merck Sharp & Dohme Corp in
healthy, adult, human subjects under fed conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/022/0524, Version: 00, Dated: 09 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Das |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
Room No:01, Ground floor, Clinical department, 16 and 18, ICBio Tower, Chikkabetahalli,
Yelahanka Main Road, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
8069423000 |
| Fax |
|
| Email |
headcl@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18, ICBio Tower, Chikkabetahalli,
Yelahanka Main Road, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18, ICBio Tower, Chikkabetahalli,
Yelahanka Main Road, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Sunglow Lifescience Private Limited, 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 Limited |
| 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 |
| Ms Sunglow Lifescience Private Limited |
Plot No 6, TVDs Flats, United Colony , 2nd Street Medavakkam Chennai (India) - 600100. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Das |
ICBio Clinical Research Private limited |
Room No:01, Ground floor, Clinical department, 16 and 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
8069423000
headcl@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Janumet XR 50 mg/ 500 mg
tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg} |
Name of the drug: Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg},
Route of administration: Oral, Frequency: single oral dose, Study duration:12 days |
| Intervention |
Sitagliptin 50 mg & Metformin
Hydrochloride 500 mg (extended release) Tablets. |
Name of the drug: Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets,
Route of administration: Oral, Frequency: single oral dose, Study duration:12 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age.
4. Body mass index in the range of 18.5 – 30.0 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 Diabetes mellitus type 1, Diabetic ketoacidosis including history of diabetic coma and precoma, acute or chronic metabolic acidosis, and Severe hepatic dysfunction (lack of experience of administration; in order to
provide adequate glycaemic control, such patients should be treated with insulin)
4. Subjects on haemodialysis (lack of experience of administration), Acute and chronic disease which may cause tissue hypoxia (cardiac or respiratory failure, acute and sub-acute myocardial infarction, shock),
5. History of severe infection or major surgery in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetic parameters: Cmax, AUC0-t and AUC0-∞ |
From Day 01 to Day 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetic parameters: Tmax, AUC_%Extrap_obs, λz and t1/2 |
From Day 01 to Day 12 |
|
|
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)
|
04/11/2024 |
| 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="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
STUDY TITLE:An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 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 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions.
Secondary objective: To monitor the safety and tolerability of the study subjects after administration of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets in healthy, adult, human subjects under fed condition.
Number of subjects: Thirty-two (32) subjects Duration of clinical study: 12 days |