| CTRI Number |
CTRI/2024/11/076249 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of K-GLiM (R) – M 2mg (Metformin
Hydrochloride Prolonged Release 500mg and Glimepiride
2 mg Tablets IP) Tablets in healthy, adult, human subjects, under fasting conditions. |
|
Scientific Title of Study
|
An Open-label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral
bioequivalence study of K-GLiM (R) – M 2mg (Metformin
Hydrochloride Prolonged Release 500mg and Glimepiride
2 mg Tablets IP) Tablets by Blue Cross Laboratories Pvt
Ltd., with Gemer (R) 2 tablets (Metformin Hydrochloride
Prolonged Release 500mg and Glimepiride 2 mg Tablets IP)
of Sun Pharmaceutical Industries Ltd in healthy, adult, human subjects, under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/025/0424, Version: 00, Dated: 12 Apr 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 |
Investigator Room No: 01, Ground floor, Clinical department, No. 2, ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, 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 |
5 th floor, Room No: 01, Director Cabin, No. 2, ICBio Tower-II, Devi Circle chikkabettahalli, Yelahanka Main Road, vidyaranapura
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 |
5 th floor, Room No: 01, Director Cabin, No. 2, ICBio Tower-II, Devi Circle chikkabettahalli, Yelahanka Main Road, vidyaranapura
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| M/s Blue Cross Laboratories Private Limited, Peninsula Chambers, Peninsula Corporate Park G. K. Marg, Lower Parel Mumbai (India) - 400013. |
|
|
Primary Sponsor
|
| Name |
Blue Cross Laboratories Pvt Ltd., |
| Address |
Peninsula Corporate Park, Peninsula Chambers, GK Marg, Lower Parel, Mumbai 400 013 |
| 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 Ankita Das |
ICBio Clinical Research Private limited |
Investigator Room No: 01, Ground floor, Clinical department, No 2, Survey No 8/1/2 ICBio tower II, Devi Circle, Yelahanka Main Road
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 |
Fasting condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gemer® 2 tablets (Metformin Hydrochloride
Prolonged Release 500mg and Glimepiride 2 mg Tablets IP) |
Name of the drug: Gemer® 2 tablets (Metformin Hydrochloride
Prolonged Release 500mg and Glimepiride 2 mg Tablets IP), Route of administration: Oral, Frequency: single oral dose, Study duration:07 days |
| Intervention |
K-GLiM® – M 2mg (Metformin
Hydrochloride Prolonged Release 500mg and Glimepiride
2 mg Tablets IP) Tablets |
Name of the drug: K-GLiM® – M 2mg (Metformin
Hydrochloride Prolonged Release 500mg and Glimepiride
2 mg Tablets IP) Tablets, Route of administration: Oral, Frequency: single oral dose, Study duration:07 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 along with chronic lymphocytic leukemia and small cell lymphocytic leukemia.
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 subacute myocardial infarction, shock).
5. History of development of lactic acidosis. |
|
|
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 and AUC0-t |
From Day 01 to Day 07 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters: AUC0-∞, Tmax, AUC_%Extrap_obs, λz and t1/2 |
From Day 01 to Day 07 |
|
|
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)
|
21/11/2024 |
| 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="7" |
|
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 K-GLiM® – M 2mg (Metformin Hydrochloride Prolonged Release 500mg and Glimepiride 2 mg Tablets IP) Tablets by Blue Cross Laboratories Pvt Ltd., with Gemer® 2 tablets (Metformin Hydrochloride Prolonged Release 500mg and Glimepiride 2 mg Tablets IP) of Sun Pharmaceutical Industries Ltd in healthy, adult, human subjects, under fasting conditions.
OBJECTIVES:
Primary objective: To compare the rate and extent of absorption of K-GLiM® – M 2mg (Metformin Hydrochloride Prolonged Release 500mg and Glimepiride 2 mg Tablets IP) Tablets by Blue Cross Laboratories Pvt Ltd., with Gemer® 2 tablets (Metformin Hydrochloride Prolonged Release 500mg and Glimepiride 2 mg Tablets IP) of Sun Pharmaceutical Industries Ltd 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 Prolonged Release 500mg and Glimepiride 2 mg Tablets in healthy, adult, human subjects, under fasting condition.
Number of subjects: Thirty-two (32) subjects Duration of clinical study: 07 days |