This study, as part of the curriculum of bioequivalence tests of domestic production, evaluates the bioequivalence of a 750 mg Metformin slow-release tablet manufactured by Kushan pharmad Pharmaceutical Company with its reference sample.
Design
Bioequivalency study of Metformin 750 mg tablet (Koushan pharmed co.) and reference product of Glucophage are evaluated in 24 healthy volunteers. This study was cross-over, open, random, and a single-blind.
Settings and conduct
This study is carried out at the central lab, Hamedan faculty of pharmacy. Twenty-four volunteers are randomly divided into two groups and are divided into two periods. This study is single-blind, and the volunteers and analyst will not know the type of product used. Blood samples were collected at a specified time and for 24 hours from each of the volunteers and then serum separated at room temperature using a centrifuge and stored at -20°C. The method used to measure the amount of drug in samples using high-performance liquid chromatography and an infrared detector.
The analysis method validation, will also be carried out. Finally, using the obtained data analysis, the pharmacokinetic parameters are calculated.
Participants/Inclusion and exclusion criteria
Healthy male subjects aged between 18 and 45 years; Normal physical examination at the screening visit; No history of diseases affecting the pharmacokinetics of the drug; Any drug intake within two (2) week prior to the study; Understanding of the study and agreement to give written informed consent; Having the Body Mass Index which is in the desirable range (+-20%IBW); Nonsmokers
Intervention groups
Bioequivalency study of Metformin tablet (Koushan pharmed co.) compare to reference product of Glucophage
Main outcome variables
Metformin plasma concentration; Area under the curve; Half-life time; Time to reach maximum plasma concentration; Maximum concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111107008022N5
Registration date:2019-03-15, 1397/12/24
Registration timing:registered_while_recruiting
Last update:2019-03-15, 1397/12/24
Update count:0
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
Katayoun Derakhshandeh
Name of organization / entity
Hamadan University of Medical Sciences, Pharmacy school
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1590
Email address
kderakhshandeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of two different Metformin 750mg formulations (Koushan pharmed & reference) in 24 Iranian volunteers
Public title
Bioequivalency study of two different Metformin formulations
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: 24 healthy male and female volunteers will participate in this study. Aged 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW Exclusion criteria: Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment
Exclusion criteria:
Age
From 20 years old to 45 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
1
Each participant in each study period will receive a single dose of Metformin
Randomization (investigator's opinion)
Randomized
Randomization description
In the first period, the test and the reference drug are randomly divided into two groups of 12 (group A and B), then in the second period, in the cross over form, the groups A and B will be received reference and test drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the volunteers, according to the predetermined random table that is available to the researcher, are in one of the groups receiving the test and reference drug. To blind the analyst and volunteers, the information collected from the drug concentration in the plasma of them is encoded and will be unlocked the codes after completion of the analysis.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Hamadan University of Medical Sciences
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Beside Mardom amusement Park, Shahid Fahmideh Blvd, Hamadan , Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-10-12, 1397/07/20
Ethics committee reference number
IR.UMSHA.REC.1397.452
Health conditions studied
1
Description of health condition studied
Health and normal volunteers
ICD-10 code
--
ICD-10 code description
--
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h following drug administration