A study to compare the relative bioavailability of Fatak Chemie Pars and Bayer formulations of acarbose 100 mg tablets in 24 healthy adult volunteers under fasting conditions
The study aims to evaluate the bioequivalence of acarbose 100 mg tablets produced by two different pharmaceutical companies under fasting conditions
Design
This 3-way, crossover study is conducted to compare the pharmacodynamics of acarbose and Glucobay® tablets in 24 healthy adult volunteers. Volunteers will be sorted and receive a number from 1 to 24. In each phase of the study, 8 volunteers will receive sucrose and 8 person will receive acarbose manufactured by Fatak Chemie Pars company plus sucrose and the remaining 8 volunteers will receive Glucobay® manufactured by Bayer company plus sucrose. The administered drugs will be replaced in each phase of the study.
Settings and conduct
The dose administration and subsequent sample collection will be performed in Motahhari hospital (Gonbade Kavous, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18-55 years; subject available for the entire study period; willingness to adhere to protocol requirements as evidenced by written informed consent; good health at screening. Exclusion criteria: History of use of any drug; hypersensitivity or intolerance; significant history or current evidence of chronic disease.
Intervention groups
First intervention group: A single dose of 75 g of sucrose to 8 subjects. Second intervention group: A single 100 mg dose of acarbose manufactured by Fatak Chemie Pars company plus 75 g of sucrose to 8 subjects. Third intervention group: A single 100 mg dose of Glucobay manufactured by Bayer company plus 75 g of sucrose to 8 subjects. Since in this study, the volunteers will receive both test and reference drugs, each volunteer will act as his own control. There will be a time interval of 1 week between interventions.
Main outcome variables
Glucose plasma concentration; Area under the plasma concentration-time curve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013776N72
Registration date:2022-07-20, 1401/04/29
Registration timing:prospective
Last update:2022-07-20, 1401/04/29
Update count:0
Registration date
2022-07-20, 1401/04/29
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
2022-10-23, 1401/08/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of Fatak Chemie Pars and Bayer formulations of acarbose 100 mg tablets in 24 healthy adult volunteers under fasting conditions
Public title
Bioequivalence study of acarbose 100 mg tablets
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years of age.
The subject is able and willing to provide signed informed consent.
The subject is available for the entire study period.
Willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has a 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 acarbose.
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of 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 a medical disorders occurring within the last year that required hospitalization or medication.
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 the present study.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
In a crossover design, each person is its own control and receives two different interventions
Randomization (investigator's opinion)
Randomized
Randomization description
A pot randomization method will be used in this study. 12 papers are labeled "Reference Product" and 12 papers are written as "Test Product". The papers are then placed in sealed envelopes, and participants randomly select a paper and will be placed in the Reference or Test groups.
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
Falsafi Building, Sari Road Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.GOUMS.REC.1401.113
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma glucose concentration
Timepoint
At time -15, 0, 10, 20, 30, 40, 50, 60 minutes, and then 1.25, 1.5, 2, 2.5, 3, 3.5 and 4 hours after drug administratio
Method of measurement
Blood sampling and measurement of plasma glucose concentrations
2
Description
Area under plasma glucose concentration-time curve
Timepoint
At time -15, 0, 10, 20, 30, 40, 50, 60 minutes, and then 1.25, 1.5, 2, 2.5, 3, 3.5 and 4 hours after drug administratio
Method of measurement
Blood sampling and measurement of plasma glucose concentrations
Secondary outcomes
1
Description
Time to reach maximum plasma glucose concentration
Timepoint
By selecting highest plasma glucose concentrations at time -15, 0, 10, 20, 30, 40, 50, 60 minutes after drug administration
Method of measurement
Blood sampling and measurement of plasma glucose
Intervention groups
1
Description
Intervention group 1: Oral administration of a single dose of 75 g of sugar to healthy volunteers under fasting conditions in the morning of the experiment day
Category
Placebo
2
Description
Intervention group 2: Oral administration of a single dose of 75 g of sugar and 100 mg dose of acarbose (1 tablet) manufactured by Fatak Chemie Pars to healthy volunteers under fasting conditions in the morning of the experiment day
Category
Treatment - Drugs
3
Description
Intervention group 3: Oral administration of a single dose of 75 g of sugar and 100 mg dose of Glucobay (1 tablet) manufactured by Bayer to healthy volunteers under fasting conditions in the morning of the experiment day