| CTRI Number |
CTRI/2023/03/050861 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare Bioequivalence of test product Sitagliptin 50 mg Metformin Hydrochloride 1000 mg extended release Tablets with reference product in healthy adult human subjects under fasting conditions |
|
Scientific Title of Study
|
An open label balanced randomized two treatment two period two sequence single oral dose crossover bioequivalence study of Sitagliptin 50 mg Metformin Hydrochloride 1000 mg extended release Tablets of SunGlow Lifescience Private Ltd in comparison with Janumet XR 50 mg 1000 mg tablets Sitagliptin and metformin HCl extended release tablets 50 mg 1000 mg of Merck Sharp Dohme Corp in healthy adult human subjects under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/032/0822 Version 00 Dated 11 Aug 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 |
Clinical department 1st floor #16&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&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&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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Janumet XR 50 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/1000 mg} |
Name of the drug: Sitagliptin 50 mg and Metformin Hydrochloride 1000 mg Route of adminnistration: Oral Frequency: single dose Duration of clinical study: 11 days |
| Intervention |
Sitagliptin 50 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets |
Name of the drug: Sitagliptin 50 mg and Metformin Hydrochloride 1000 mg
Route of adminnistration: 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)
|
22/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NONE |
|
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 50 mg &
Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private
Ltd., in
comparison with Janumet XR 50 mg/
1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50
mg/1000 mg} of Merck
Sharp & Dohme Corp in healthy, adult,
human subjects under fasting conditions.
OBJECTIVES: Primary objective:
To compare the rate and extent of absorption of Sitagliptin
50 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow
Lifescience Private Ltd., with
that of Janumet XR 50 mg/ 1000 mg tablets {Sitagliptin and metformin HCl
(extended release) tablets 50 mg/1000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under
fasting condition.
Secondary objective:
To
monitor the safety and tolerability of the study subjects after administration
of Sitagliptin 50 mg & Metformin Hydrochloride 1000 mg (extended release)
Tablets in healthy, adult, human subjects
under fasting condition.
Number of subjects: Thirty two (32) Duration of clinical study: 11 days |