The bioequivalence study of amlodipin- valsartan tablet manufactured by Alborz Darou company and Exforge tablet manufactured by Novartis company.
Design
Bioequivalence study, cross over, single blinded, randomized on 24 healthy volunteers, for randomization the rand function of excel was used.
Settings and conduct
Sampling of volunteers is done in Khorazmi Plasma Center in Islamshar. On the day of sampling, one 10/160 mg tablets of Amlodipine- valsartan manufactured by Alborz Darou or Novartis on two occasions and with a washout period of 14 days, will be administered orally with 240 ml of water to the volunteer. For example, if in the first period of administration, he received the Alborz Darou drug, he will receive Exforge, two weeks later. In each phase, 5 cc of blood sample will be taken at 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 4.5، 6، 8، 10، 12، 24, 32 hours after prescribing the medicine . Three weeks after the start of the study, the volunteer's cooperation in this research ends. The way to cooperate in these three weeks is that the drug is prescribed in the first day and after that 32 hours blood sampling is done at the mentioned times after washout period of two weeks the other drug is administered and blood samples will be taken at the same time
Participants/Inclusion and exclusion criteria
Healthy volunteers, in the age range of 18 to 55 years with a body mass index between 18 and 27 kg per square meter of the body, volunteers who are willing to comply with the requirements of the protocol and provide written informed consent. Exclusion citeria is smokers or smokers who smoke more than 10 cigarettes per day.
Intervention groups
The first group: 12 people who take Alborz Darou tablets.
The second group: 12 people who take Novartis tablets on the same day.
Main outcome variables
Plasma concentration and area under the curve of plasma concentration time of test and reference drug
General information
Reason for update
Acronym
هم ارزی زیستی
IRCT registration information
IRCT registration number:IRCT20220209053979N5
Registration date:2023-02-04, 1401/11/15
Registration timing:prospective
Last update:2023-02-04, 1401/11/15
Update count:0
Registration date
2023-02-04, 1401/11/15
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
2023-02-23, 1401/12/04
Expected recruitment end date
2023-03-09, 1401/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence Study of amlodipine valsartan 10/160 mg manufactured by Alborz Darou and Exforge manufactured by Novartis in 24 Healthy Volunteers
Public title
Bioeqivalence study of amlodipine valsartan 10/160 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory tests +/- 10% of normal interval
without any history of chronic sickness
Exclusion criteria:
Systolic blood pressure less than 90 and diastolic less than 60 mm Hg
Smoking more than 10 cigarette per day
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
At times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration, 5 ml of blood is taken from each volunteer.
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand option of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and the test drug, and the other half will receive numbers 13-24 and will receive the reference drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
The tablets of Alborz Daru and Novartis are both oval shaped and pink in color, so the candidate does not know which company's drug he will receive in each phase of the study. On the other hand, the tubes of the volunteers' samples are also coded, so the analyzer does not know which company's drug he is analyzing, so only the researcher and the prescriber know which company's drug is being prescribed.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, 16 Azar St.,
City
Tehran
Province
Tehran
Postal code
1417713135
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR. TUMS. TIPS. REC. 1401. 106
Health conditions studied
1
Description of health condition studied
Bioequivalence study
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma concentration time profile,
Timepoint
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration
Method of measurement
Liquid chromatography with mass spectrophotometry
Secondary outcomes
1
Description
Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug.
Timepoint
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration
Method of measurement
Pharmacokientic parameters are calculated by excel.
Intervention groups
1
Description
Intervention group: 1 oral administration of one amlodipine valsartan 10/160 mg tablet manufactured by Alborz Daru Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Novartis medicine and give blood samples at 16 time points
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral administration of a 160/10 amlodipine valsartan tablet manufactured by Novartis to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Alborz Daru's medicine and give blood samples at 16 time points
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi plasma center
Full name of responsible person
Sara Solgi
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,