| CTRI Number |
CTRI/2022/03/040735 [Registered on: 02/03/2022] 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 of Metformin Hydrochloride 1000 mg XR tablet of in comparison with Glucophage 1000 mg XR tablet 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 Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., in comparison with Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/037/1021 version 00 dated 04 Oct 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadiyala Venkata Sahitya |
| 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
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Labratories Leti S.A.V.
Zona Industrial del Este, Avenida 2, Edif. Leti. Guarenas, Edo Miranda, APDO.17.22, Republica Bolivariana de Venezuela |
|
|
Primary Sponsor
|
| Name |
Labratories 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 Kadiyala Venkata Sahitya |
ICBio Clinical Research Pvt. Ltd. |
# 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 |
healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glucophage 1000 mg XR tablet |
single dose one time only one day |
| Intervention |
Metformin Hydrochloride 1000 mg XR tablet |
single dose one time only one day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 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 18-55 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 (gm/dl) for men and 12 to 16 gm/dl for female or as per the discretion of PI/CI/Physician.
6.Normal health status as determined by medical history and physical examination by the PI/CI/Physician at the time of screening and vital signs (blood pressure)
7 With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
8 With a normal or clinically non-significant 12-lead ECG.
9 With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies, Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) antibodies.
|
|
| 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.
6.Any major illness or hospitalization within 90 days prior to check-in of first period.
7.Any other clinical condition like diarrhea or vomiting within three days prior to check-in of any period.
8.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post study safety sample is collected.
9.Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the rate and extent of absorption of orally administered Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., with that of Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions.
-Cmax, and AUC0-t and
|
Day 1 to day 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the safety and tolerability of the study subjects after administration of Metformin Hydrochloride 1000 mg XR tablet in healthy adult human subjects under fasting conditions.
Tmax, λz and t1/2 |
Day 1 to day 11 during the study |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2022 |
| Date of Study Completion (India) |
08/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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 of Metformin Hydrochloride 1000 XR tablet mg of Laboratorios
LETI S.A.V., in comparison with Glucophage 1000 mg XR tablet (Metformin
Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting
conditions.
Primary objective:
To compare the
rate and extent of absorption of orally administered Metformin Hydrochloride 1000
mg XR tablet of Laboratorios
LETI S.A.V., with that of Glucophage 1000 mg XR tablet (Metformin
Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects
under fasting conditions. Secondary objective:
To monitor the safety and tolerability of the
study subjects after administration of Metformin Hydrochloride 1000 mg XR tablet in
healthy adult human subjects under fasting conditions. 26 Normal healthy subjects will be enrolling in the study. |