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A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition

Protocol summary

Study aim
to compare plasma concentration of losartan hydrochlorothiazide tab manufactured by Alborz Darou versus Hyzaar manufactured by Merck
Design
A randomized, double blind, single-dose, crossover study is conducted to compare the pharmacokinetic of losartan-hydrochlorothiazide 50/12.5 mg Alborz Darou (test) and Hyzaar® tablet manufactured by Merck in 24 healthy adults volunteers under fasting condition. For randomization, volunteers are divided into two groups using the RAND function of Excel software, and they are coded . Depending on the code, they receive one of the test and reference drugs
Settings and conduct
One day before the study, the test and reference tablets, which are completely similar in appearance, are packed in a disposable container . Volunteers come to the Khorazmi plasma center in Islamshahr, A single dose of one tablet of test or reference drug is administered to volunteers with 240 ml water and blood samples are taken at specified time, and then samples are transferred to the -20 freezer. Since samples are coded, the analyzer does not know which sample is analysed. so this study is double blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Healthy adult non-smokers subjects, 2. Between 18 to 45 years 3. Blood pressure more than 110/70 mmHg. exclusion Criteria: 1. history of any heart, renal, GI diseases 2. consumption of any medication within 1 month prior to the study 3. participation in any other clinical study in the past 3 months
Intervention groups
First intervention group: A single tablet of losartan hydrochlorothiazide manufactured by Alborz Darou company to 12 subjects. Second intervention group: A single dose of Hyzaar manufactured by Merck company to 12 subjects. in the next week it is vise verse.
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: IRCT20220209053979N2
Registration date: 2022-07-07, 1401/04/16
Registration timing: retrospective

Last update: 2022-07-07, 1401/04/16
Update count: 0
Registration date
2022-07-07, 1401/04/16
Registrant information
Name
Roya Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 0892
Email address
talari_r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-30, 1401/04/09
Expected recruitment end date
2022-07-07, 1401/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition
Public title
A bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Sex: male.Age: 18 - 55 years. . BMI of 18-27 kg/m2 with minimum of 50 kg weight. Volunteer willing to adhere to the protocol requirements and to provide written informed consent Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion criteria:
Clinically relevant abnormalities in the results of the laboratory screening evaluation. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 50/minute or more than 100/minute. History of allergy to the test drug or any drug chemically similar to the drug under investigation. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 16
6 ml blood samples
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Since both Alborz Daru and the reference tablets are manufactured in the same size and white color , it is possible to make blinded.The drug (test drug or reference drug) is packed in small disposable containers a day before the study, Therefore, the volunteer does not know which drug he is taking. Each volunteer is also assigned a code that the analyzer does not know which drug the volunteer received in each phase of the study.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences
Street address
Tehran University of medical science, 16 Azar St., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.021

Health conditions studied

1

Description of health condition studied
Blood concentration of test and reference drug is compared
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The plasma concentrations of the test and reference drugs is compared. A total of 16 blood samples are taken from each volunteer at different times
Timepoint
, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration
Method of measurement
liquid chromatography mass spectrometry (LCMSMS)

Secondary outcomes

1

Description
Plasma concentration of the drug and consequently y pharmacokinetic parameters such as maximum plasma concentration and area under curve of the concentration-time profile of test and reference drug
Timepoint
, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration
Method of measurement
Plasma concentration of the drug is analyzed by liquid chromatography with mass detector

Intervention groups

1

Description
Intervention group: Oral administration of a single dose of 1 tablet of losartan H 50/12.5 mg of Alborz Darou to 12 healthy volunteers under fasting condition with 240 ml water, then 15 blood samples are taken from each volunteer at specified times. In the second phase,this group will received the losartan H 50/12.5 mg of Merck and 15 blood samples are taken from them.
Category
Treatment - Drugs

2

Description
Intervention group: Oral administration of a single dose of 1 tablet of losartan H 50/12.5 mg of Merck to 12 healthy volunteers under fasting condition with 240 ml water, then 15 blood samples are taken from each volunteer at specified times. In the second phase,this group will received the losartan H 50/12.5 mg of Alborz Darou and 15 blood samples are taken from them.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kharazmi Plasma Center (Islamshahr)
Full name of responsible person
Sara Solgi
Street address
No. 13, Shahamat 1 Alley, Ali Ibn Abitaleb St., Namaz Square, Islamshahr, Tehran
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Fax
+98 21 5637 8236
Email
Info@kpcir.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz Darou
Full name of responsible person
Delara Vahidi
Street address
No. 3 , Navak St., Jahan kudak Intersection, Afrigha BLV, Tehran
City
Tehran
Province
Tehran
Postal code
1518646177
Phone
+98 21 8819 2773
Email
info@alborzdarouco.com
Grant name
The cost is provided by Alborz Daroo
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz Darou
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

Person responsible for general inquiries

Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Islamshahr
City
Tehran
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Islamshahr
City
Tehran
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Fax
+98 21 5637 8236
Email
talari_r@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Islamshahr
City
Tehran
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The study is confidential and it is not possible to publish the data without the permission of the manufacturer
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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