A study to compare the relative bioavailability of Raha and Merck formulations of metformin 1000 mg tablets in 24 healthy adult male volunteers under fasting conditions
The study aims to compare the bioequivalence study of metformin hydrochloride 1000 mg tablets under fasting conditions
Design
This randomized, single-dose, two-way, crossover study is conducted to compare the relative bioavailability of two formulations of metformin hydrochloride tablets under fasting conditions in 24 healthy adults male volunteers.
Settings and conduct
The dose administration and subsequent sample collection will be performed in Payambar-Azam hospital (Gonbade Kavous, Iran)
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. Presence of a medical condition requiring regular treatment with prescription drugs. 5. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Intervention groups
Single dose of metformin 1000 mg tablets manufactured by Raha and Merck companies
Main outcome variables
Drug plasma concentration; Area under the plasma concentration-time curve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013776N6
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of Raha and Merck formulations of metformin 1000 mg tablets in 24 healthy adult male volunteers under fasting conditions
Public title
Bioequivalence study of metformin hydrochloride 1000 mg tablets under fasting conditions
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Males, 18-50 years of age (inclusive).
The subject is able and willing to provide written informed consent.
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has stable residence and telephone.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Exclusion criteria:
History of allergy or sensitivity to metformin hydrochloride history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
Presence of a medical condition requiring regular treatment with prescription drugs.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to dosing.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
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
Table of random numbers was used.
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 Golestan University of Medical Sciences
Street address
Gorgan, Shast cola road, Falsafi Building
City
Gorgan
Province
Golestan
Postal code
4916817693
Approval date
2017-12-25, 1396/10/04
Ethics committee reference number
IR.GOUMS.REC.1396.232
Health conditions studied
1
Description of health condition studied
Healthy volunteers
ICD-10 code
---
ICD-10 code description
---
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
Before intervention and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention
Method of measurement
Blood sampling and measurement of drug concentrations by HPLC
2
Description
Area under plasma concentration-time curve
Timepoint
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention
Method of measurement
Blood sampling and measurement of drug concentrations by HPLC
Secondary outcomes
1
Description
Time to reach Cmax
Timepoint
During 4 hours after drug administration
Method of measurement
Blood sampling and drug analysis by HPLC
Intervention groups
1
Description
Intervention group: Single dose of Rahamet (metformin 1000 mg) tablet manufactured by Raha Pharmaceuticals
Category
Treatment - Drugs
2
Description
Intervention group: Single dose of Glucophage (metformin 1000 mg) tablet manufactured by Merck Pharmaceuticals
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar Azam Hospital
Full name of responsible person
Yahya Naseri Fard
Street address
Gonbad-Incheboroun Road Km1
City
Gonbad Kavous
Province
Golestan
Postal code
4916817693
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Web page address
http://goums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Raha Pharmaceuticals
Full name of responsible person
Dr. Akram Sharifian
Street address
Central Office:No.11, Sofeh Ind. Zone, 7th km of Shiraz Road
City
isfehan
Province
Isfehan
Postal code
81745-567
Phone
+98 31 3654 0659
Fax
+98 31 3654 0183
Email
info@rahapharma.com
Web page address
http://rahapharm.com/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raha Pharmaceuticals
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
ِDr. Mohammad Reza Honarvar
Street address
Sari Road Km 2,
City
Gorgan
Province
Golestan
Postal code
4916817693
Phone
+98 17 3245 9995
Fax
+98 17 3245 9995
Email
dr.roshandel@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?