The aim of these studies is to compare the absorption of two formulations of the same drug (famotidine oral tablet 40 mg).
Design
Bioequivalence studies (bioequivalence) of famotidine 40 mg tablets manufactured by Aria Pharmaceutical Company compared to famotidine 40 mg manufactured by Joint Stock Company of Belarus include in vivo tests after administration to 24 healthy human volunteers with ethical approval and covered by liability insurance. .
Settings and conduct
On-site study: Nik Azma Pars Alborz Company (collaborating laboratory of the honorable Food and Drug Organization in the field of analysis of pharmaceutical and supplement products)
The week is the washout period (when the drug is completely out of your blood). Each stage lasts for 12 hours.
The total duration of participation of the candidates in both stages of this study will be a total of 24 hours, In the first stage of the study, you will be randomly assigned to one of the following two groups: group one consumes formula A and group two consumes formula B. Formulas A and B are products in the form of tablets produced in Iran and Belarus.
Participants/Inclusion and exclusion criteria
A: Entry criteria:
- Be between 18 and 50 years old.
- All candidates must be non-smokers.
- The body mass index (BMI) of the candidate must be less than 30 kg/m2.
B: Non-entry criteria:
- Volunteers with blood pressure lower than 60.90 mm Hg or higher than 90.90 mm Hg.
- Candidates should refrain from smoking, consuming alcohol, caffeine (including coffee, cocoa, tea, cola drinks) 48 hours before the start of the study.
Intervention groups
The volunteers were in the age group of 18 to 50 years and were healthy and non-smokers. The study started fasting The study will be cross-over with a washing time of one week.
Main outcome variables
C max, t max, AUC
General information
Reason for update
Acronym
IVSF
IRCT registration information
IRCT registration number:IRCT20230222057495N1
Registration date:2023-03-05, 1401/12/14
Registration timing:prospective
Last update:2023-03-05, 1401/12/14
Update count:0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-09-04, 1402/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo study of famotidine tablet 40 mg, iranian product compare to the brand one on healthy volunteers
Public title
In vivo study of famotidine tablet 40 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 50 years
Non smoking
BMI below 30 kg/m2
Exclusion criteria:
Blood pressure below 90/60 or more than 140/90 mmHg
Smoking person (more than 10 /day)
Using any kinds of medicine, alcohol or opioids during 2 weeks before starting the study
Age
From 18 years old to 50 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:
30
Every sample, is obtained during 15 time intervals sampling, as 5 cc, from each volunteer. This is repeated two times (totally 30 samples from every volunteers)
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmacetical science Institude of Tehran university of medical science
Street address
Poursina Ave, Tehran University of Medical Science, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences
Intervention group: The study consists of two phases (taking a famotidine 40 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Each stage lasts for 12 hours. You must fast for 10 hours before the start of each stage. On the morning of the study, you must be present at the place of the study at 7:00 a.m. to have an angiocath installed on your arm and for 12 hours. It will remain on your hand. 5 ml of blood before taking the medicine and during sampling times in minutes: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600, 720 will be taken from you (15 times in total). With a gap of one week after receiving the first drug, the candidates must go to receive another drug and all these steps will be repeated. The total duration of participation of the candidates in both stages of this study will be a total of 24 hours, during which the candidates are covered by Pasargad insurance and financially supported by Aria Pharmaceutical Company (as the employer in this study). In the first stage of the study, you will be randomly assigned to one of the following two groups: group one consumes formula A and group two consumes formula B. Formulas A and B are products in the form of tablets produced in Belarus and Iran.