Bioequivalence evaluation of furosemide 40 mg tablet manufactured by the Aburyhan and the Lasix 40mg tablet manufactured by the sanofi in healthy human volunteers
To evaluate the pharmacokinetic parameters obtained after the single oral administration of the drug from either Furosemide or Lasix preparations
Design
This cross-over study will be done on 24 normal subjects. They were randomly allocated into two groups. After overnight fasting, they will receive one tablet from either Aburyhan or Sanofi pharmaceutical companies on two working days separated by a wash-out period of two weeks. They are not allowed to eat any consumption up to 3 hours at this time will receive a simple breakfast. Blood samples will be collected, at suitable intervals.
Settings and conduct
Madar pathobiology Lab
Participants/Inclusion and exclusion criteria
Inclusion Criteria
(1) Written informed consent.
( 2) Normal findings in the physical examination.
(3) Clinical laboratory values within 10% above or below the laboratory’s stated normal range
(4) To be a non-smoker
Exclusion Criteria
(1) History of hypersensitivity to the study drug or related products.
(2) Significant history or presence of gastrointestinal, liver or kidney disease,
3) Any clinically significant illness during the 4 weeks prior to the study.
(4) History of drug dependence, alcohol abuse, or serious neurological or psychological disease.
(5) Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
(6) Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study.
(7) HIV and Hepatitis A, B and C positive subjects.
Intervention groups
Subjects receiving Aburyhan -manufactured drug
Subjects receiving Sanofi-manufactured drug
Main outcome variables
Pharmacokinetic parameters include Elimination half-life, Area under the concentration-time curve up to sampling time, Area under the concentration-time curve up to infinity, Maximum concentration and Time to maximum concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110523006565N4
Registration date:2024-11-03, 1403/08/13
Registration timing:prospective
Last update:2024-11-03, 1403/08/13
Update count:0
Registration date
2024-11-03, 1403/08/13
Registrant information
Name
Gholam Reza Bahrami
Name of organization / entity
Kermanhsah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 1562
Email address
gbahrami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-08, 1403/08/18
Expected recruitment end date
2024-11-22, 1403/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence evaluation of furosemide 40 mg tablet manufactured by the Aburyhan and the Lasix 40mg tablet manufactured by the sanofi in healthy human volunteers
Public title
Bioequivalence study of Furosemide
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent.
Normal findings in the physical examination.
Clinical laboratory values within 10% above or below the laboratory’s stated normal range
To be a non-smoker
Exclusion criteria:
History of hypersensitivity to the study drug or related products
Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the pharmacokinetics of the drug
Any clinically significant illness during the 4 weeks prior to day 1 of this study
Maintenance therapy with any drug, or history of drug dependence
Alcohol abuse, or serious neurological or psychological disease
Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study
Positive test of HIV and Hepatitis A, B and C
Age
From 18 years old to 40 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization:
For this purpose, first a total sample size (24 people) is determined, then the people of groups 1 and 2 will be selected by paper lottery. Thus the volunteers are divided in of test/reference and reference/test sequences.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-blind study, information that could confound the results should be hidden from the subjects. Therefore they are not informed about the branding of the drugs. Test and reference dosage forms are removed from their boxes and placed in similar and coded cans and given to volunteers.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of Kermanshah University of Medical Sciences and Health Services