| CTRI Number |
CTRI/2022/03/041021 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tablet |
|
Scientific Title of Study
|
An Open label, balanced, randomized, twotreatment, twoperiod, twosequence, single oral dose, crossover, bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., Vs Janumet 100 and 1000 mg XR tablet Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg of Merck Sharp and Dohme Corp in healthy adult human subjects under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/017/0521 version 00 dated 25 May 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh Dharmapuri |
| Designation |
Principal investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Laboratorios LETI SAV |
| Address |
Zona Industrial del Este, Avenida 2, Edif. Leti. Guarenas, Edo Miranda, APDO.17.22, Republica Bolivariana de Venezuela |
| 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 Naresh |
ICBio Clinical Research Pvt. Ltd. |
#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
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 |
healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Janumet XR tablet |
Single dose one time only |
| Intervention |
Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg tablet |
Single dose one time only |
|
|
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 – 30 kg/m2 (both inclusive).
5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female.
6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
|
|
| ExclusionCriteria |
| Details |
1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening.
2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
5.History of severe infection or major surgery in the past 6 months.
6.History of Minor surgery or fracture within the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC0-t and AUC0-∞ |
From day 1 to day 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tmax , Extrap_obs, λz and t1/2 |
From day 1 to day 12 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2022 |
| Date of Study Completion (India) |
08/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open label, balanced, randomized,
two-treatment, two-period, two-sequence, single oral dose, crossover,
bioequivalence study on Sitagliptin Phosphate 100 mg + Metformin Hydrochloride
1000 mg XR tablet of Laboratorios LETI S.A.V., Vs Janumet 100/1000 mg XR tablet
(Sitagliptin Phosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp
& Dohme Corp in healthy adult human subjects under fasting conditions. Test product (T):
Sitagliptin Phosphate 100 mg + Metformin
Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V
Reference product (R):
Janumet 100/1000 mg XR tablet (Sitagliptin
Phosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp & Dohme Corp 24 subjects will be enrolled in the study .
Primary objective: To compare rate
and extend of orally administered molecule to prove bioequivalence on Sitagliptin
Phosphate 100 mg + Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI
S.A.V., with Janumet 100/1000 mg
XR tablet (Sitagliptin
Phosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp & Dohme Corp in healthy adult human subjects under fasting
conditions. Secondary objective:
To monitor the safety of the study subjects
after administration of Sitagliptin Phosphate 100 mg + Metformin Hydrochloride 1000
mg XR tablets
in healthy adult human subjects under fasting conditions. |