This study will be performed to compare the pharmacokinetics and invivo parameters of metformin 1000 mg E.R. Tablet formulation as a test product with Glucophage® capsule formulation as a reference product and to evaluate the biocompatibility of these two formulations.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy males under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). 2 dosing periods will be separated by a 21-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Exclusion Criteria: History of known sensitivity to the tested products
Associated acute or chronic infections
Intervention groups
Intervention group (test): Metformin 1000 mg E.R. Tablet, produced by َDorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group (Reference): Glucophage® capsule, produced by Merckis the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N67
Registration date:2024-06-23, 1403/04/03
Registration timing:prospective
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Metformin 1000 mg E.R. Tablet of Dorsa Pharmaceutical Co and Merck
Public title
Bioequivalence study of Metformin 1000 mg E.R. Tablet in 24 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Exclusion criteria:
History of known sensitivity to the tested products
Associated acute or chronic infections
Blood pressure in standing position and after 5 minutes of rest, systole less than 90 or more than 140 mm Hg and diastole less than 50 or more than 90 mm Hg.
Heart rate less than 50 or more than 90 beats per minute
Abnormalities in ECG include (PR > 210 msec, QRS complex > 120 msec, QTcF > 430 msec)
Smoking more than 10 cigarettes a day
Loss of more than 500 ml of blood in less than 7 days.
Age
From 18 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with the BEAR statistical software (Release V2.7.7). Each volunteer will be randomly assigned to one of the 2 different sequence of treatments according to the order of entering the study which will be allocated after screening.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.038
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
15 blood samples will be withdrawn pre-dose and at 1, 1.5, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Secondary outcomes
1
Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
15 blood samples will be withdrawn pre-dose and at 1, 1.5, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Intervention groups
1
Description
Intervention group1(test): Metformin 1000 mg E.R. Tablet, produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group 2 (refrence): Metformin 1000 mg E.R. Tablet, produced by Merck is the refrence product. In each period, 12 of 24 subjects will be given single oral dose of this product.